PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Description of Event or Problem

BASED ON REAL WORLD DATA FROM THE AUSTRALIAN ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY THA PROCEDURES: - R3 0 DEGREE XLPE LINER COMPONENTS: IMPLANTED IN EIGHTEEN THOUSAND THREE HUNDRED TWENTY-EIGHT (18,328) HIPS BETWEEN (B)(6) 2008 AND (B)(6) 2026. THIS INCLUDES SIZE VARIANTS APPROVED FOR USE IN THE UNITED STATES UNDER PRO CODES JDI AND LPH. FROM THESE, SIX HUNDRED AND TWENTY (620) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE HUNDRED AND FIFTY SIX (156) HIPS DUE TO PERIPROSTHETIC FRACTURE, SEVENTY SEVEN (77) HIPS DUE TO LOOSENING, ONE HUNDRED AND FIFTY NINE (159) HIPS DUE TO INFECTION, ONE HUNDRED AND FIFTY NINE (159) HIPS DUE TO PROSTHESIS DISLOCATION, ONE (1) HIP DUE TO LYSIS, EIGHT (8) HIPS DUE TO PAIN, FIFTEEN (15) HIPS DUE TO INSTABILITY, FIFTEEN (15) HIPS DUE TO LEG LENGTH DISCREPANCY, NINE (9) HIPS DUE TO MALPOSITION, FOUR (4) HIPS DUE TO IMPLANT BREAKAGE ¿ STEM, TWO (2) HIPS DUE TO METAL RELATED PATHOLOGY, ONE (1) HIP DUE TO WEAR ¿ ACETABULAR INSERT, TWO (2) HIPS DUE TO INCORRECT SIZING, TWO (2) HIPS DUE TO TUMOUR, ONE (1) HIP DUE TO HETEROTOPIC BONE, AND NINE (9) HIPS DUE TO OTHER-UNKNOWN REASONS. A DISTINCTION BETWEEN THE COMPLICATIONS ASSOCIATED WITH PRODUCTS REGISTERED UNDER PRO CODES JDI AND LPH CANNOT BE ESTABLISHED. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 620 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 610 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A R3 0 DEGREE XLPE LINER APPROVED UNDER FDA PRODUCT CODE JDI. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 610 CASES. - R3 20 DEGREE XLPE LINER COMPONENTS: IMPLANTED IN THIRTY-FIVE THOUSAND EIGHT HUNDRED SEVENTY-SIX (35,876) HIPS BETWEEN (B)(6) 2006 AND (B)(6) 2026. THIS INCLUDES SIZE VARIANTS APPROVED FOR USE IN THE UNITED STATES UNDER PRO CODES JDI AND MBL. FROM THESE, ONE THOUSAND TWO HUNDRED SEVENTY TWO (1,272) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWO HUNDRED EIGHTY SIX (286) HIPS DUE TO FRACTURE, ONE HUNDRED FIFTY SEVEN (157) HIPS DUE TO LOOSENING, THREE HUNDRED FORTY ONE (341) HIPS DUE TO INFECTION, THREE HUNDRED FORTY (340) HIPS DUE TO PROSTHESIS DISLOCATION, SIX (6) HIPS DUE TO LYSIS, EIGHTEEN (18) HIPS DUE TO PAIN, TWENTY FIVE (25) HIPS DUE TO INSTABILITY, NINETEEN (19) HIPS DUE TO LEG LENGTH DISCREPANCY, NINETEEN (19) HIPS DUE TO MALPOSITION, THIRTEEN (13) HIPS DUE TO IMPLANT BREAKAGE ¿ STEM, TWO (2) HIPS DUE TO METAL RELATED PATHOLOGY, ONE (1) HIP DUE TO WEAR ¿ ACETABULAR INSERT, THREE (3) HIPS DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, THREE (3) HIPS DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, SEVEN (7) HIPS DUE TO INCORRECT SIZING, TWO (2) HIPS DUE TO TUMOUR, FOUR (4) HIPS DUE TO HETEROTOPIC BONE, AND TWENTY-SIX (26) HIPS DUE TO OTHER-UNKNOWN REASONS. A DISTINCTION BETWEEN THE COMPLICATIONS ASSOCIATED WITH PRODUCTS REGISTERED UNDER PRO CODES JDI AND MBL CANNOT BE ESTABLISHED. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 1,272 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 1,254 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A R3 20 DEGREE XLPE LINER APPROVED UNDER FDA PRODUCT CODE JDI. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 1,254 CASES. OF THE 1,254 TOTAL REVISION SURGERIES, 1,145 WERE PREVIOUSLY SUBMITTED TO FDA AND 109 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. - SPECTRON EF COCR HIGH OFFSET STEM COMPONENTS: IMPLANTED IN FOUR THOUSAND THREE HUNDRED AND FIFTY-TWO (4,352) HIPS BETWEEN (B)(6) 1999 AND (B)(6) 2025. FROM THESE, THREE HUNDRED AND THIRTY-FOUR (334) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWENTY-NINE (29) HIPS DUE TO FRACTURE, ONE HUNDRED AND SIXTY-TWO (162) HIPS DUE TO LOOSENING, SIXTY-TWO (62) HIPS DUE TO INFECTION, FIFTY-ONE (51) HIPS DUE TO PROSTHESIS DISLOCATION, FIFTEEN (15) HIPS DUE TO LYSIS, THREE (3) HIPS DUE TO INSTABILITY, ONE (1) HIP DUE TO MALPOSITION, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ STEM, TWO (2) HIPS DUE TO METAL RELATED PATHOLOGY, FOUR (4) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, TWO (2) HIPS DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, ONE (1) HIP DUE TO INCORRECT SIZING, AND ONE (1) HIP DUE TO OTHER- UNKNOWN REASONS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. OF THE 334 TOTAL REVISION SURGERIES, 324 WERE PREVIOUSLY SUBMITTED TO FDA AND 10 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. - SPECTRON EF REVISION STEM COMPONENTS: IMPLANTED IN ONE HUNDRED AND EIGHTEEN (118) HIPS BETWEEN (B)(6) 1999 AND (B)(6) 2026. FROM THESE, SEVEN (7) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE (1) HIP DUE TO FRACTURE, ONE (1) HIP DUE TO LOOSENING, TWO (2) HIPS DUE TO INFECTION, TWO (2) HIPS DUE TO PROSTHETIC DISLOCATION AND ONE (1) HIP DUE TO LYSIS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. OF THE 7 TOTAL REVISION SURGERIES, 6 WERE PREVIOUSLY SUBMITTED TO FDA AND 1 NEW REVISION WAS IDENTIFIED DURING THIS REPORTING QUARTER. - REFLECTION XLPE LINER COMPONENTS: IMPLANTED IN THIRTEEN THOUSAND NINE HUNDRED AND SEVENTY-ONE (13,971) HIPS BETWEEN (B)(6) 2000 AND (B)(6) 2025. THIS TOTAL INCLUDES REFLECTION XLPE LINER COMPONENTS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES JDI AND LPH. OF THE FIVE HUNDRED SIXTY-NINE (569) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, FOUR HUNDRED SIXTY-FIVE (465) REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION XLPE LINER COMPONENT APPROVED UNDER FDA PRODUCT CODE JDI. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 569 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE JDI. THE REPORTED REASONS FOR REVISION INCLUDE: ONE HUNDRED AND THIRTY-SIX (136) HIPS DUE TO FRACTURE, ONE HUNDRED AND FORTY-FOUR (144) HIPS DUE TO LOOSENING, ONE HUNDRED AND TEN (110) HIPS DUE TO INFECTION, ONE HUNDRED AND FIFTEEN (115) HIPS DUE TO PROSTHESIS DISLOCATION, NINETEEN (19) HIPS DUE TO LYSIS, EIGHT (8) HIPS DUE TO PAIN, SEVEN (7) HIPS DUE TO INSTABILITY, SIX (6) HIPS DUE TO LEG LENGTH DISCREPANCY, FIVE (5) HIPS DUE TO MALPOSITION, SIX (6) HIPS DUE TO IMPLANT BREAKAGE ¿ STEM, THREE (3) HIPS DUE TO METAL RELATED PATHOLOGY, TWO (2) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, TWO (2) HIPS DUE TO INCORRECT SIZING, ONE (1) HIP DUE TO TUMOUR AND THREE (3) HIPS DUE TO OTHER-UNKNOWN REASONS. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 569 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 465 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION XLPE LINER COMPONENT APPROVED UNDER FDA PRODUCT CODE JDI. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 465 CASES. OF THE 465 TOTAL REVISION SURGERIES, 454 WERE PREVIOUSLY SUBMITTED TO FDA AND 11 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. - REFLECTION XLPE ALL-POLY CUP COMPONENTS: IMPLANTED IN ONE THOUSAND NINE HUNDRED AND FORTY-THREE (1,943) HIPS BETWEEN (B)(6) 2003 AND (B)(6) 2026. OF THESE, EIGHTY-SIX (86) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: SEVENTEEN (17) HIPS DUE TO FRACTURE, TWENTY-SEVEN (27) DUE TO LOOSENING, TWENTY-THREE (23) DUE TO INFECTION, FOURTEEN (14) DUE TO PROSTHESIS DISLOCATION, ONE (1) DUE TO LYSIS, ONE (1) DUE TO INSTABILITY, ONE (1) DUE TO IMPLANT BREAKAGE OF THE STEM, ONE (1) DUE TO IMPLANT BREAKAGE OF THE ACETABULAR COMPONENT, ONE (1) DUE TO WEAR OF THE ACETABULUM. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. OF THE 86 TOTAL REVISION SURGERIES, 82 WERE PREVIOUSLY SUBMITTED TO FDA AND 4 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. 2. REVISION THA PROCEDURES: - REFLECTION XLPE ALL-POLY CUP COMPONENTS: IMPLANTED IN SIXTY-TWO (62) HIPS BETWEEN (B)(6) 2004 AND (B)(6) 2025. OF THESE, THIRTEEN (13) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: TWO (2) HIPS DUE TO PROSTHESIS DISLOCATION, TWO (2) DUE TO LOOSENING, FIVE (5) DUE TO INFECTION, FOUR (4) DUE TO FRACTURE. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR RE-REVISION. OF THE 13 TOTAL RE-REVISION SURGERIES, 11 WERE PREVIOUSLY SUBMITTED TO FDA AND 2 NEW RE-REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. ALTOGETHER, A TOTAL QUANTITY OF 745 REVISIONS AND 2 RE-REVISIONS (747 EVENTS IN TOTAL) WERE IDENTIFIED DURING THE CURRENT REPORTING QUARTER BASED ON THE AUSTRALIAN ORTHOPAEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR) FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT.

Additional Manufacturer Narrative

REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2026) SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AUSTRALIAN ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY THA PROCEDURES: - R3 0 DEGREE XLPE LINER COMPONENTS: IMPLANTED IN EIGHTEEN THOUSAND THREE HUNDRED TWENTY-EIGHT (18,328) HIPS BETWEEN (B)(6) 2008 AND (B)(6) 2026. THIS INCLUDES SIZE VARIANTS APPROVED FOR USE IN THE UNITED STATES UNDER PRO CODES JDI AND LPH. FROM THESE, SIX HUNDRED AND TWENTY (620) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE HUNDRED AND FIFTY SIX (156) HIPS DUE TO PERIPROSTHETIC FRACTURE, SEVENTY SEVEN (77) HIPS DUE TO LOOSENING, ONE HUNDRED AND FIFTY NINE (159) HIPS DUE TO INFECTION, ONE HUNDRED AND FIFTY NINE (159) HIPS DUE TO PROSTHESIS DISLOCATION, ONE (1) HIP DUE TO LYSIS, EIGHT (8) HIPS DUE TO PAIN, FIFTEEN (15) HIPS DUE TO INSTABILITY, FIFTEEN (15) HIPS DUE TO LEG LENGTH DISCREPANCY, NINE (9) HIPS DUE TO MALPOSITION, FOUR (4) HIPS DUE TO IMPLANT BREAKAGE ¿ STEM, TWO (2) HIPS DUE TO METAL RELATED PATHOLOGY, ONE (1) HIP DUE TO WEAR ¿ ACETABULAR INSERT, TWO (2) HIPS DUE TO INCORRECT SIZING, TWO (2) HIPS DUE TO TUMOUR, ONE (1) HIP DUE TO HETEROTOPIC BONE, AND NINE (9) HIPS DUE TO OTHER-UNKNOWN REASONS. A DISTINCTION BETWEEN THE COMPLICATIONS ASSOCIATED WITH PRODUCTS REGISTERED UNDER PRO CODES JDI AND LPH CANNOT BE ESTABLISHED. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 620 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 610 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A R3 0 DEGREE XLPE LINER APPROVED UNDER FDA PRODUCT CODE JDI. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 610 CASES. - R3 20 DEGREE XLPE LINER COMPONENTS: IMPLANTED IN THIRTY-FIVE THOUSAND EIGHT HUNDRED SEVENTY-SIX (35,876) HIPS BETWEEN (B)(6) 2006 AND (B)(6) 2026. THIS INCLUDES SIZE VARIANTS APPROVED FOR USE IN THE UNITED STATES UNDER PRO CODES JDI AND MBL. FROM THESE, ONE THOUSAND TWO HUNDRED SEVENTY TWO (1,272) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWO HUNDRED EIGHTY SIX (286) HIPS DUE TO FRACTURE, ONE HUNDRED FIFTY SEVEN (157) HIPS DUE TO LOOSENING, THREE HUNDRED FORTY ONE (341) HIPS DUE TO INFECTION, THREE HUNDRED FORTY (340) HIPS DUE TO PROSTHESIS DISLOCATION, SIX (6) HIPS DUE TO LYSIS, EIGHTEEN (18) HIPS DUE TO PAIN, TWENTY FIVE (25) HIPS DUE TO INSTABILITY, NINETEEN (19) HIPS DUE TO LEG LENGTH DISCREPANCY, NINETEEN (19) HIPS DUE TO MALPOSITION, THIRTEEN (13) HIPS DUE TO IMPLANT BREAKAGE ¿ STEM, TWO (2) HIPS DUE TO METAL RELATED PATHOLOGY, ONE (1) HIP DUE TO WEAR ¿ ACETABULAR INSERT, THREE (3) HIPS DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, THREE (3) HIPS DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, SEVEN (7) HIPS DUE TO INCORRECT SIZING, TWO (2) HIPS DUE TO TUMOUR, FOUR (4) HIPS DUE TO HETEROTOPIC BONE, AND TWENTY-SIX (26) HIPS DUE TO OTHER-UNKNOWN REASONS. A DISTINCTION BETWEEN THE COMPLICATIONS ASSOCIATED WITH PRODUCTS REGISTERED UNDER PRO CODES JDI AND MBL CANNOT BE ESTABLISHED. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 1,272 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 1,254 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A R3 20 DEGREE XLPE LINER APPROVED UNDER FDA PRODUCT CODE JDI. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 1,254 CASES. OF THE 1,254 TOTAL REVISION SURGERIES, 1,145 WERE PREVIOUSLY SUBMITTED TO FDA AND 109 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. - SPECTRON EF COCR HIGH OFFSET STEM COMPONENTS: IMPLANTED IN FOUR THOUSAND THREE HUNDRED AND FIFTY-TWO (4,352) HIPS BETWEEN (B)(6) 1999 AND (B)(6) 2025. FROM THESE, THREE HUNDRED AND THIRTY-FOUR (334) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWENTY-NINE (29) HIPS DUE TO FRACTURE, ONE HUNDRED AND SIXTY-TWO (162) HIPS DUE TO LOOSENING, SIXTY-TWO (62) HIPS DUE TO INFECTION, FIFTY-ONE (51) HIPS DUE TO PROSTHESIS DISLOCATION, FIFTEEN (15) HIPS DUE TO LYSIS, THREE (3) HIPS DUE TO INSTABILITY, ONE (1) HIP DUE TO MALPOSITION, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ STEM, TWO (2) HIPS DUE TO METAL RELATED PATHOLOGY, FOUR (4) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, TWO (2) HIPS DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, ONE (1) HIP DUE TO INCORRECT SIZING, AND ONE (1) HIP DUE TO OTHER- UNKNOWN REASONS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. OF THE 334 TOTAL REVISION SURGERIES, 324 WERE PREVIOUSLY SUBMITTED TO FDA AND 10 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. - SPECTRON EF REVISION STEM COMPONENTS: IMPLANTED IN ONE HUNDRED AND EIGHTEEN (118) HIPS BETWEEN (B)(6) 1999 AND (B)(6) 2026. FROM THESE, SEVEN (7) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE (1) HIP DUE TO FRACTURE, ONE (1) HIP DUE TO LOOSENING, TWO (2) HIPS DUE TO INFECTION, TWO (2) HIPS DUE TO PROSTHETIC DISLOCATION AND ONE (1) HIP DUE TO LYSIS. IT SHOULD BE NOTED THAT, BASED ON THE DATA STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DISTINCTLY MATCHED TO THE CORRESPONDING MEDICAL DEVICES INVOLVED IN EACH REVISION CASE. OF THE 7 TOTAL REVISION SURGERIES, 6 WERE PREVIOUSLY SUBMITTED TO FDA AND 1 NEW REVISION WAS IDENTIFIED DURING THIS REPORTING QUARTER. - REFLECTION XLPE LINER COMPONENTS: IMPLANTED IN THIRTEEN THOUSAND NINE HUNDRED AND SEVENTY-ONE (13,971) HIPS BETWEEN (B)(6) 2000 AND (B)(6) 2025. THIS TOTAL INCLUDES REFLECTION XLPE LINER COMPONENTS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES JDI AND LPH. OF THE FIVE HUNDRED SIXTY-NINE (569) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, FOUR HUNDRED SIXTY-FIVE (465) REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION XLPE LINER COMPONENT APPROVED UNDER FDA PRODUCT CODE JDI. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 569 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE JDI. THE REPORTED REASONS FOR REVISION INCLUDE: ONE HUNDRED AND THIRTY-SIX (136) HIPS DUE TO FRACTURE, ONE HUNDRED AND FORTY-FOUR (144) HIPS DUE TO LOOSENING, ONE HUNDRED AND TEN (110) HIPS DUE TO INFECTION, ONE HUNDRED AND FIFTEEN (115) HIPS DUE TO PROSTHESIS DISLOCATION, NINETEEN (19) HIPS DUE TO LYSIS, EIGHT (8) HIPS DUE TO PAIN, SEVEN (7) HIPS DUE TO INSTABILITY, SIX (6) HIPS DUE TO LEG LENGTH DISCREPANCY, FIVE (5) HIPS DUE TO MALPOSITION, SIX (6) HIPS DUE TO IMPLANT BREAKAGE ¿ STEM, THREE (3) HIPS DUE TO METAL RELATED PATHOLOGY, TWO (2) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, TWO (2) HIPS DUE TO INCORRECT SIZING, ONE (1) HIP DUE TO TUMOUR AND THREE (3) HIPS DUE TO OTHER-UNKNOWN REASONS. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 569 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 465 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION XLPE LINER COMPONENT APPROVED UNDER FDA PRODUCT CODE JDI. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 465 CASES. OF THE 465 TOTAL REVISION SURGERIES, 454 WERE PREVIOUSLY SUBMITTED TO FDA AND 11 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. - REFLECTION XLPE ALL-POLY CUP COMPONENTS: IMPLANTED IN ONE THOUSAND NINE HUNDRED AND FORTY-THREE (1,943) HIPS BETWEEN (B)(6) 2026. OF THESE, EIGHTY-SIX (86) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: SEVENTEEN (17) HIPS DUE TO FRACTURE, TWENTY-SEVEN (27) DUE TO LOOSENING, TWENTY-THREE (23) DUE TO INFECTION, FOURTEEN (14) DUE TO PROSTHESIS DISLOCATION, ONE (1) DUE TO LYSIS, ONE (1) DUE TO INSTABILITY, ONE (1) DUE TO IMPLANT BREAKAGE OF THE STEM, ONE (1) DUE TO IMPLANT BREAKAGE OF THE ACETABULAR COMPONENT, ONE (1) DUE TO WEAR OF THE ACETABULUM. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR REVISION. OF THE 86 TOTAL REVISION SURGERIES, 82 WERE PREVIOUSLY SUBMITTED TO FDA AND 4 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. 2. REVISION THA PROCEDURES: - REFLECTION XLPE ALL-POLY CUP COMPONENTS: IMPLANTED IN SIXTY-TWO (62) HIPS BETWEEN (B)(6) 2025. OF THESE, THIRTEEN (13) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: TWO (2) HIPS DUE TO PROSTHESIS DISLOCATION, TWO (2) DUE TO LOOSENING, FIVE (5) DUE TO INFECTION, FOUR (4) DUE TO FRACTURE. DUE TO THE STRATIFICATION PROVIDED BY THE JOINT REGISTRY, THE SPECIFIC REASONS FOR EACH REVISION PROCEDURE CANNOT BE DIRECTLY CORRELATED WITH THE INDIVIDUAL PART NUMBERS REPORTED. AS SUCH, IT IS NOT POSSIBLE TO DETERMINE WHICH SPECIFIC PART NUMBERS WERE ASSOCIATED WITH WHICH SPECIFIC REASONS FOR RE-REVISION. OF THE 13 TOTAL RE-REVISION SURGERIES, 11 WERE PREVIOUSLY SUBMITTED TO FDA AND 2 NEW RE-REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. ALTOGETHER, A TOTAL QUANTITY OF 745 REVISIONS AND 2 RE-REVISIONS (747 EVENTS IN TOTAL) WERE IDENTIFIED DURING THE CURRENT REPORTING QUARTER BASED ON THE AUSTRALIAN ORTHOPAEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR) FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE R3 ,REFLECTION ACETABULAR, REFLECTION XLPE ALL-POLY CUP AND SPECTRON EF HIP SYSTEMS PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENTS WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THESE SYSTEMS ARE AT LEAST AS SAFE AND EFFECTIVE AS ALL THEIR THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. AOANJRR REPORTS THAT FOR THE R3 0 DEGREE XLPE LINERS, R3 20 DEGREE XLPE LINERS, REFLECTION XLPE ALL-POLY CUPS AND REFLECTION XLPE ACETABULAR LINER COMPONENTS WERE IN LINE OR BETTER WITH THE CLASS ACROSS ALL YEARS OF FOLLOW-UP. FOR THE SPECTRON EF HIGH OFFSET STEMS, THE CUMULATIVE REVISION RATES WERE LOWER OR IN LINE WITH THE CLASS AT 1-6 YEARS. AT LATER POINTS, THE CUMULATIVE REVISION RATES WERE HIGHER THAN THE CLASS AS SHOWN BY NON-OVERLAPPING CONFIDENCE INTERVALS. THE INCIDENCE OF REVISION DUE TO LOOSENING, WEAR ACETABULAR INSERT, AND LYSIS WERE HIGHER IN THE SPECTRON EF HIGH OFFSET STEMS COMPARED TO CLASS, HOWEVER NO STATISTICAL ANALYSIS CAN BE PERFORMED TO ASSESS IF THIS DIFFERENCE IS STATISTICALLY SIGNIFICANT. OTHER REASONS FOR REVISION WERE LOWER OR IN LINE WITH THE CLASS. THE SPECTRON EF HIP SYSTEM HAS BEEN UTILIZED WITH A VARIETY OF ACETABULAR SYSTEMS, INCLUDING OLDER SYSTEMS COUPLED WITH CONVENTIONAL POLYETHYLENE (CPE) LINERS. LINERS OF CPE MATERIAL HAD A HIGHER WEAR RATE COMPARED TO THE CURRENTLY USED XLPE MATERIAL. THE REGISTRY REPORT PROVIDED FURTHER STRATIFICATION OF THE 334 REVISIONS BASED ON THE BEARING SURFACE USED IN COMBINATION WITH SPECTRON EF HIGH OFFSET STEMS. WHEN COMPARED TO THE CLASS AVERAGE REVISIONS PER 100 OBSERVED COMPONENT YEARS (0.71, CI: 0.64, 0.79), THE COMBINATIONS PERFORMING WORSE THAN THE CLASS AVERAGE ARE CERAMIC/NON XLPE (1.63, CI: 0.84, 2.84), METAL/METAL (2.92, CI: 0.35, 10.55), METAL/NON XLPE (1.24, CI: 1.02, 1.49), CERAMICISED METAL/NON XLPE (1.39, CI: 0.66, 2.55), CERAMICISED METAL/XLPE (0.78, CI: 0.63, 0.96) AND ¿UNKNOWN¿ (0.80, CI: 0.02, 4.46). THE COMBINATIONS INVOLVING CPE INCREASE THE REVISION RATE OF THE SPECTRON EF COCR HIGH OFFSET DATA. CPE IS NO LONGER OFFERED IN STANDARD ACETABULAR LINERS, WHERE PREVIOUSLY AVAILABLE. ADDITIONALLY, THE REVISIONS PER 100 OBSERVED YEARS OF THE METAL-ON-METAL COMBINATION MAY NOT BE STATISTICALLY SIGNIFICANTLY HIGHER WHEN COMPARED TO ALL OTHER TOTAL CONVENTIONAL HIP CLASS (0.71, CI: 0.64, 0.79) WHEN BASED ON OVERLAPPING CONFIDENCE INTERVALS, BUT THE REVISION RATE IS MUCH HIGHER. IT IS WELL DOCUMENTED THAT BOTH METAL-ON-METAL AND BEARING SURFACES CONTAINING CONVENTIONAL POLYETHYLENE COMBINATIONS HAVE INHERENTLY HIGHER REVISION RATES DUE TO INCREASED PARTICLE DEBRIS AND WEAR RATES IN PRIMARY TOTAL HIP ARTHROPLASTIES. SMITH & NEPHEW, INC. NO LONGER SELLS CONVENTIONAL POLYETHYLENE OR METAL LINERS FOR USE IN TOTAL HIP ARTHROPLASTY. FOR THE SPECTRON EF REVISION STEMS, THE CUMULATIVE REVISION RATES WERE IN LINE WITH THE CLASS AT 1 AND 3 YEARS. AT 2 AND 4 YEARS, THE CUMULATIVE REVISION RATES WERE HIGHER THAN THE CLASS AS SHOWN BY NON-OVERLAPPING CONFIDENCE INTERVALS. OVERALL, CONFIDENCE INTERVALS WERE WIDE DUE TO THE LOW VOLUME OF RECORDED IMPLANTATIONS. THE TENDENCY TO HIGHER REVISION RATES THAN THE CLASS FOR SPECTRON REVISION STEM IS AT LEAST IN PART DRIVEN BY THEM BEING MOSTLY USED FOR COMPLEX PRIMARY IN WHICH MAY LED TO HIGHER RISK FOR REVISION (B)(4) CASES OF FAILED INTERNAL FIXATION AND (B)(4) CASES OF FRACTURED NECK OF FEMUR, BOTH OF WHICH REPRESENT A 59,3% OF THE TOTAL USAGE AT PRIMARY THA). THIS MAY PRESENT SIMILAR CHALLENGES AS REVISION PROCEDURES. THE INCIDENCE OF REVISIONS DUE TO LOOSENING, INFECTION, PROSTHESIS DISLOCATION, AND LYSIS WAS HIGHER FOR THE SPECTRON EF REVISION STEM COMPARED TO THE CLASS. HOWEVER, NO STATISTICAL ANALYSIS WAS AVAILABLE FOR THESE SPECIFIC REVISION INDICATIONS, AND THEREFORE IT CANNOT BE DETERMINED WHETHER THE OBSERVED DIFFERENCES ARE STATISTICALLY SIGNIFICANT. REVISION RATES FOR OTHER REPORTED INDICATIONS WERE LOWER THAN OR COMPARABLE TO THE CLASS. IT IS ALSO NOTED THAT THE SPECTRON EF HIP SYSTEM HAS HISTORICALLY BEEN USED WITH A VARIETY OF ACETABULAR SYSTEMS, INCLUDING OLDER SYSTEMS UTILIZING CONVENTIONAL POLYETHYLENE (CPE) LINERS. PUBLISHED EVIDENCE HAS DEMONSTRATED THAT, COMPARED WITH CROSS-LINKED POLYETHYLENE (XLPE), CPE IS ASSOCIATED WITH HIGHER RATES OF REVISION RELATED TO LOOSENING, LYSIS, AND DISLOCATION. THEREFORE, THE USE OF CPE BEARINGS MAY HAVE CONTRIBUTED, AT LEAST IN PART, TO THE OBSERVED DIFFERENCES BETWEEN THE SPECTRON EF REVISION STEM COHORT AND THE CLASS. INFECTION IS RECOGNIZED AS A COMPLICATION ASSOCIATED WITH PATIENT AND PROCEDURE-RELATED RISK FACTORS, INCLUDING SURGICAL ENVIRONMENT AND HOST SUSCEPTIBILITY, AND IS NOT CONSIDERED AN INHERENT COMPLICATION OF THE DEVICE. IN CONSIDERATION OF THE DIFFERENCES IN PATIENT INDICATIONS, CASE COMPLEXITY, AND BEARING CHARACTERISTICS BETWEEN THE SPECTRON EF REVISION STEM COHORT AND THE CLASS, THE OBSERVED REVISION RATES ARE CONSIDERED TO BE INFLUENCED, AT LEAST IN PART, BY THESE CONFOUNDING FACTORS. THE IDENTIFIED REASONS FOR REVISION ARE CONSISTENT WITH RECOGNIZED COMPLICATIONS OF TOTAL HIP ARTHROPLASTY AND DO NOT IDENTIFY NEW OR UNEXPECTED SAFETY CONCERNS. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Description of Event or Problem

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2026-00322139-1-L1,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L2,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L3,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L4,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L5,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L6,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L7,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L8,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L9,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L10,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L11,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L12,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L13,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L14,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L15,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L16,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L17,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L18,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L19,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L20,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L21,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L22,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L23,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L24,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L25,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L26,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L27,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L28,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L29,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L30,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L31,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L32,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L33,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L34,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L35,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L36,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L37,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L38,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L39,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L40,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L41,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L42,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L43,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L44,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L45,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L46,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L47,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L48,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L49,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L50,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L51,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L52,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L53,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L54,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L55,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L56,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L57,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L58,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L59,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L60,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L61,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L62,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L63,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L64,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L65,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L66,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L67,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L68,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L69,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L70,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L71,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L72,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L73,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L74,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L75,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L76,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L77,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L78,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L79,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L80,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L81,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L82,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L83,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L84,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L85,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L86,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L87,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L88,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L89,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L90,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L91,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L92,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L93,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L94,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L95,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L96,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L97,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L98,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L99,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L100,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L101,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L102,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L103,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L104,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L105,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L106,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L107,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L108,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L109,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L110,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L111,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L112,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71332752,,71332752,,03596010597984,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L113,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L114,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L115,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L116,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L117,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L118,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L119,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L120,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L121,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L122,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L123,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L124,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L125,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L126,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L127,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L128,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L129,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L130,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L131,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L132,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L133,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L134,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L135,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L136,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L137,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L138,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L139,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L140,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L141,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L142,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L143,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L144,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L145,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L146,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L147,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L148,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L149,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L150,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L151,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L152,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L153,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L154,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L155,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L156,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L157,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L158,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L159,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L160,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L161,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L162,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L163,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L164,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L165,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L166,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L167,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L168,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L169,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L170,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L171,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L172,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L173,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L174,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L175,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L176,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L177,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L178,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L179,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L180,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L181,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L182,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L183,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L184,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L185,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L186,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L187,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L188,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L189,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L190,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L191,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L192,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L193,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L194,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L195,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L196,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L197,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L198,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L199,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L200,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L201,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L202,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L203,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L204,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L205,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L206,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L207,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L208,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L209,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L210,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L211,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L212,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L213,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L214,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L215,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L216,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L217,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L218,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L219,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L220,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L221,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L222,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L223,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L224,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L225,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L226,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L227,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L228,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L229,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L230,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L231,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L232,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L233,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L234,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L235,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L236,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L237,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L238,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L239,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L240,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L241,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L242,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L243,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L244,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L245,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L246,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L247,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L248,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L249,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L250,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L251,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L252,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L253,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L254,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L255,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L256,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L257,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L258,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L259,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L260,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L261,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L262,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L263,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L264,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L265,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L266,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L267,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L268,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L269,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L270,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L271,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L272,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L273,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L274,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L275,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L276,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71332756,,71332756,,03596010598004,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L277,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L278,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L279,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L280,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L281,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L282,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L283,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L284,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L285,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L286,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L287,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L288,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L289,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L290,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L291,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L292,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L293,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L294,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L295,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L296,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L297,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L298,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L299,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L300,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L301,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L302,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L303,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L304,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L305,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L306,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L307,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L308,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L309,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L310,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L311,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L312,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L313,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L314,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L315,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L316,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L317,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L318,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L319,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L320,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L321,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L322,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L323,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 58MM,71332758,,71332758,,03596010598011,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L324,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L325,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L326,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L327,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L328,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L329,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L330,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L331,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L332,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L333,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L334,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L335,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L336,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L337,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L338,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L339,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L340,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L341,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71332760,,71332760,,03596010598028,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L342,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 62MM,71332762,,71332762,,03596010598035,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L343,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 62MM,71332762,,71332762,,03596010598035,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L344,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 62MM,71332762,,71332762,,03596010598035,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L345,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 62MM,71332762,,71332762,,03596010598035,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L346,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 62MM,71332762,,71332762,,03596010598035,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L347,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 62MM,71332762,,71332762,,03596010598035,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L348,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 62MM,71332762,,71332762,,03596010598035,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L349,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 62MM,71332762,,71332762,,03596010598035,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L350,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 64MM,71332764,,71332764,,03596010598042,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L351,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 64MM,71332764,,71332764,,03596010598042,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L352,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 64MM,71332764,,71332764,,03596010598042,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L353,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 64MM,71332764,,71332764,,03596010598042,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L354,,,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM ID X OD 66/68MM,71332766,,71332766,,03596010598059,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L355,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE +4 XLPE ACETABULAR LINER 32MM ID X OD 48MM,71336648,,71336648,,03596010622471,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L356,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE +4 XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71336952,,71336952,,03596010622556,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L357,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE +4 XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71336952,,71336952,,03596010622556,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L358,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE +4 XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71336952,,71336952,,03596010622556,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L359,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE +4 XLPE ACETABULAR LINER 36MM ID X OD 54MM,71336954,,71336954,,03596010622563,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L360,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE +4 XLPE ACETABULAR LINER 36MM ID X OD 54MM,71336954,,71336954,,03596010622563,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L361,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE +4 XLPE ACETABULAR LINER 36MM ID X OD 54MM,71336954,,71336954,,03596010622563,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L362,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE +4 XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71336956,,71336956,,03596010622570,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L363,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE +4 XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71336956,,71336956,,03596010622570,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L364,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE +4 XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71336956,,71336956,,03596010622570,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L365,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE +4 XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM,71336956,,71336956,,03596010622570,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L366,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE +4 XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71336960,,71336960,,03596010622594,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L367,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE +4 XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71336960,,71336960,,03596010622594,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L368,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE +4 XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 64MM,71336964,,71336964,,03596010622617,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L369,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 46MM,71337546,,71337546,,03596010598455,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L370,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 46MM,71337546,,71337546,,03596010598455,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L371,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 46MM,71337546,,71337546,,03596010598455,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L372,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 46MM,71337546,,71337546,,03596010598455,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L373,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 46MM,71337546,,71337546,,03596010598455,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L374,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 46MM,71337546,,71337546,,03596010598455,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L375,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 46MM,71337546,,71337546,,03596010598455,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L376,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 46MM,71337546,,71337546,,03596010598455,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L377,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 46MM,71337546,,71337546,,03596010598455,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L378,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 46MM,71337546,,71337546,,03596010598455,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L379,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 46MM,71337546,,71337546,,03596010598455,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L380,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 46MM,71337546,,71337546,,03596010598455,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L381,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 46MM,71337546,,71337546,,03596010598455,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L382,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 48MM,71337548,,71337548,,03596010598462,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L383,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 50MM,71337550,,71337550,,03596010615190,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L384,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 50MM,71337550,,71337550,,03596010615190,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L385,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 50MM,71337550,,71337550,,03596010615190,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L386,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 52MM,71337552,,71337552,,03596010615206,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L387,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 54MM,71337554,,71337554,,03596010615213,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L388,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 54MM,71337554,,71337554,,03596010615213,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L389,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 28MM ID X OD 56MM,71337556,,71337556,,03596010615220,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L390,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L391,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L392,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L393,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L394,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L395,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L396,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L397,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L398,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L399,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L400,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L401,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L402,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L403,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L404,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L405,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L406,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L407,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L408,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L409,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L410,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L411,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L412,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L413,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L414,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L415,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L416,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L417,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L418,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L419,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L420,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L421,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L422,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L423,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L424,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L425,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L426,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L427,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L428,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L429,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L430,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L431,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L432,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L433,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L434,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L435,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L436,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L437,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L438,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L439,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L440,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM,71339548,,71339548,,03596010598790,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L441,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L442,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L443,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L444,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L445,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L446,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L447,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L448,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L449,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L450,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L451,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L452,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L453,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L454,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L455,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L456,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L457,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L458,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L459,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L460,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L461,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L462,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L463,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L464,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L465,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L466,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L467,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L468,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L469,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L470,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L471,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L472,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L473,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L474,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L475,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L476,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L477,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L478,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L479,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L480,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L481,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L482,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L483,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L484,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L485,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L486,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L487,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L488,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L489,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L490,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L491,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L492,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L493,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L494,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L495,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L496,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L497,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L498,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L499,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L500,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L501,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L502,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L503,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L504,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L505,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L506,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L507,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L508,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L509,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L510,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L511,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L512,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L513,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L514,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L515,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L516,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L517,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L518,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L519,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L520,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L521,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L522,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L523,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L524,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L525,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L526,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L527,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L528,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L529,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L530,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L531,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L532,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L533,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L534,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L535,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L536,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L537,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L538,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L539,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L540,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L541,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L542,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L543,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L544,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 50MM,71339550,,71339550,,03596010598806,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L545,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L546,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L547,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L548,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L549,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L550,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L551,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L552,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L553,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L554,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L555,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L556,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L557,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L558,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L559,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L560,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L561,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L562,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L563,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L564,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L565,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L566,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L567,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L568,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L569,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L570,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L571,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L572,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L573,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L574,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L575,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L576,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L577,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L578,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L579,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM X 52MM OUTER DIAMETER,71339552,,71339552,,03596010583086,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L580,,,4/1/2026,R3 Acetabular System,R3 O DEGREE XLPE ACETABULAR 32MM ID X 54MM OD,71339554,,71339554,,03596010583093,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L581,,,4/1/2026,R3 Acetabular System,R3 O DEGREE XLPE ACETABULAR 32MM ID X 54MM OD,71339554,,71339554,,03596010583093,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L582,,,4/1/2026,R3 Acetabular System,R3 O DEGREE XLPE ACETABULAR 32MM ID X 54MM OD,71339554,,71339554,,03596010583093,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L583,,,4/1/2026,R3 Acetabular System,R3 O DEGREE XLPE ACETABULAR 32MM ID X 54MM OD,71339554,,71339554,,03596010583093,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L584,,,4/1/2026,R3 Acetabular System,R3 O DEGREE XLPE ACETABULAR 32MM ID X 54MM OD,71339554,,71339554,,03596010583093,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L585,,,4/1/2026,R3 Acetabular System,R3 O DEGREE XLPE ACETABULAR 32MM ID X 54MM OD,71339554,,71339554,,03596010583093,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L586,,,4/1/2026,R3 Acetabular System,R3 O DEGREE XLPE ACETABULAR 32MM ID X 54MM OD,71339554,,71339554,,03596010583093,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L587,,,4/1/2026,R3 Acetabular System,R3 O DEGREE XLPE ACETABULAR 32MM ID X 54MM OD,71339554,,71339554,,03596010583093,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L588,,,4/1/2026,R3 Acetabular System,R3 O DEGREE XLPE ACETABULAR 32MM ID X 54MM OD,71339554,,71339554,,03596010583093,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L589,,,4/1/2026,R3 Acetabular System,R3 O DEGREE XLPE ACETABULAR 32MM ID X 54MM OD,71339554,,71339554,,03596010583093,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L590,,,4/1/2026,R3 Acetabular System,R3 O DEGREE XLPE ACETABULAR 32MM ID X 54MM OD,71339554,,71339554,,03596010583093,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L591,,,4/1/2026,R3 Acetabular System,R3 O DEGREE XLPE ACETABULAR 32MM ID X 54MM OD,71339554,,71339554,,03596010583093,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L592,,,4/1/2026,R3 Acetabular System,R3 O DEGREE XLPE ACETABULAR 32MM ID X 54MM OD,71339554,,71339554,,03596010583093,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L593,,,4/1/2026,R3 Acetabular System,R3 O DEGREE XLPE ACETABULAR 32MM ID X 54MM OD,71339554,,71339554,,03596010583093,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L594,,,4/1/2026,R3 Acetabular System,R3 O DEGREE XLPE ACETABULAR 32MM ID X 54MM OD,71339554,,71339554,,03596010583093,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L595,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 56MM,71339556,,71339556,,03596010615251,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L596,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 56MM,71339556,,71339556,,03596010615251,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L597,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 56MM,71339556,,71339556,,03596010615251,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L598,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 56MM,71339556,,71339556,,03596010615251,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L599,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 56MM,71339556,,71339556,,03596010615251,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L600,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 56MM,71339556,,71339556,,03596010615251,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L601,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 56MM,71339556,,71339556,,03596010615251,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L602,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 56MM,71339556,,71339556,,03596010615251,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L603,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 56MM,71339556,,71339556,,03596010615251,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L604,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 58MM,71339558,,71339558,,03596010615268,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L605,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 58MM,71339558,,71339558,,03596010615268,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L606,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 58MM,71339558,,71339558,,03596010615268,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L607,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 58MM,71339558,,71339558,,03596010615268,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L608,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 58MM,71339558,,71339558,,03596010615268,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L609,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 60MM,71339560,,71339560,,03596010615275,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00322139-1-L610,,,4/1/2026,R3 Acetabular System,R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 60MM,71339560,,71339560,,03596010615275,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual liner reported through this line item. ","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighteen thousand three hundred twenty eight (18,328) hips underwent primary THA procedures between 30-Jan-2008 and 12-Feb-2026, using R3 0 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and LPH. From these, six hundred and twenty (620) hips were later revised due to the following reasons: one hundred and fifty six (156) hips due to periprosthetic fracture, seventy seven (77) hips due to loosening, one hundred and fifty nine (159) hips due to infection, one hundred and fifty nine (159) hips due to prosthesis dislocation, one (1) hip due to lysis, eight (8) hips due to pain, fifteen (15) hips due to instability, fifteen (15) hips due to leg length discrepancy, nine (9) hips due to malposition, four (4) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, two (2) hips due to incorrect sizing, two (2) hips due to tumour, one (1) hip due to heterotopic bone, and nine (9) hips due to other-unknown reasons. ;;A distinction between the complications associated with products registered under PRO codes JDI and LPH cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 620 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 610 revisions associated with hips that had previously received a R3 0 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 610 cases.;;Timeframe of Registry data: Implantations conducted between 30-Jan-2008 and 12-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of eighteen thousand three hundred twenty eight (18,328) procedures with R3 0 degree XLPE Liners have been performed in Australia between 30-Jan-2008 and 12-Feb-2026. ;;The mean cumulative revision rates for the R3 0 degree XLPE Liners were in line with the class across 17 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.2% (2.0%¿2.4%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.5% (2.2%¿2.7%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 2.9% (2.7%¿3.2%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.1% (2.8%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.3% (3.0%¿3.5%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.5% (3.2%¿3.8%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.6% (3.3%¿3.9%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 3.9% (3.6%¿4.2%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.1% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.3% (3.9%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.7% (4.3%¿5.2%) vs 5.5% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.9% (4.4%¿5.4%) vs 6.0% (5.9%¿6.0%) of the class.;-At 14th postoperative year: 5.1% (4.6%¿5.7%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.6%¿5.7%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 5.4% (4.6%¿6.2%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 6.3% (4.6%¿8.6%) vs 7.8% (7.7%¿7.9%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279072-1-L1146,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 46MM,71334946,,71334946,,03596010598097,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1147,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 52MM,71334952,,71334952,,03596010598127,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1148,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1149,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1150,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1151,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1152,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1153,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1154,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1155,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1156,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1157,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1158,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1159,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1160,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1161,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1162,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1163,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1164,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1165,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1166,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1167,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM,71335752,,71335752,,03596010598332,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1168,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1169,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1170,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1171,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1172,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1173,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1174,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1175,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1176,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1177,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1178,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1179,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1180,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1181,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1182,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1183,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1184,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1185,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1186,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1187,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 54MM,71335754,,71335754,,03596010598349,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1188,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 56MM,71335756,,71335756,,03596010598356,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1189,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 56MM,71335756,,71335756,,03596010598356,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1190,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 56MM,71335756,,71335756,,03596010598356,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1191,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 56MM,71335756,,71335756,,03596010598356,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1192,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 56MM,71335756,,71335756,,03596010598356,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1193,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 56MM,71335756,,71335756,,03596010598356,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1194,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 56MM,71335756,,71335756,,03596010598356,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1195,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 56MM,71335756,,71335756,,03596010598356,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1196,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 56MM,71335756,,71335756,,03596010598356,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1197,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 56MM,71335756,,71335756,,03596010598356,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1198,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 56MM,71335756,,71335756,,03596010598356,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1199,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 56MM,71335756,,71335756,,03596010598356,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1200,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 56MM,71335756,,71335756,,03596010598356,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1201,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 58MM,71335758,,71335758,,03596010598363,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1202,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 58MM,71335758,,71335758,,03596010598363,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1203,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 58MM,71335758,,71335758,,03596010598363,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1204,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 58MM,71335758,,71335758,,03596010598363,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1205,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 58MM,71335758,,71335758,,03596010598363,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1206,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 58MM,71335758,,71335758,,03596010598363,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1207,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 58MM,71335758,,71335758,,03596010598363,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1208,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 58MM,71335758,,71335758,,03596010598363,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1209,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 58MM,71335758,,71335758,,03596010598363,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1210,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71335760,,71335760,,03596010598370,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1211,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 62MM,71335762,,71335762,,03596010598387,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1212,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 62MM,71335762,,71335762,,03596010598387,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1213,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 48MM,71337648,,71337648,,03596010598479,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1214,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 48MM,71337648,,71337648,,03596010598479,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1215,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 48MM,71337648,,71337648,,03596010598479,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1216,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 48MM,71337648,,71337648,,03596010598479,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1217,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 48MM,71337648,,71337648,,03596010598479,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1218,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 48MM,71337648,,71337648,,03596010598479,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1219,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 48MM,71337648,,71337648,,03596010598479,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1220,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 48MM,71337648,,71337648,,03596010598479,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1221,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 48MM,71337648,,71337648,,03596010598479,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1222,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 48MM,71337648,,71337648,,03596010598479,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1223,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 48MM,71337648,,71337648,,03596010598479,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1224,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1225,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1226,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1227,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1228,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1229,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1230,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1231,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1232,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1233,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1234,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1235,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1236,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1237,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1238,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1239,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1240,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1241,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337650,,71337650,,03596010598486,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1242,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 52MM,71337652,,71337652,,03596010598493,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1243,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 52MM,71337652,,71337652,,03596010598493,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1244,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 52MM,71337652,,71337652,,03596010598493,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1245,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 52MM,71337652,,71337652,,03596010598493,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1246,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 52MM,71337652,,71337652,,03596010598493,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1247,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 52MM,71337652,,71337652,,03596010598493,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1248,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 54MM,71337654,,71337654,,03596010598509,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1249,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 54MM,71337654,,71337654,,03596010598509,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1250,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 54MM,71337654,,71337654,,03596010598509,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1251,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 56MM,71337656,,71337656,,03596010598516,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1252,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 56MM,71337656,,71337656,,03596010598516,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1253,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 58MM,71337658,,71337658,,03596010598523,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279072-1-L1254,,,4/1/2026,R3 Acetabular System,R3 20 DEGREE +4 XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 50MM,71337950,,71337950,,03596010598646,K113848,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using a R3 20 degree XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty five thousand eight hundred seventy?six (35,876) hips underwent primary THA procedures between 04-Dec-2006 and 20-Feb-2026, using R3 20 degree XLPE Liners. This includes size variants approved for use in the United States under PRO codes JDI and MBL. From these, one thousand two hundred seventy two (1,272) hips were later revised due to the following reasons: two hundred eighty six (286) hips due to fracture, one hundred fifty seven (157) hips due to loosening, three hundred forty one (341) hips due to infection, three hundred forty (340) hips due to prosthesis dislocation, six (6) hips due to lysis, eighteen (18) hips due to pain, twenty five (25) hips due to instability, nineteen (19) hips due to leg length discrepancy, nineteen (19) hips due to malposition, thirteen (13) hips due to implant breakage ¿ stem, two (2) hips due to metal related pathology, one (1) hip due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, seven (7) hips due to incorrect sizing, two (2) hips due to tumour, four (4) hips due to heterotopic bone, and twenty-six (26) hips due to other-unknown reasons. ;A distinction between the complications associated with products registered under PRO codes JDI and MBL cannot be established. ;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 1,272 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 1,254 revisions associated with hips that had previously received a R3 20 degree XLPE Liner approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 1,254 cases.;;Timeframe of Registry data: Implantations conducted between 04-Dec-2006 and 20-Feb-2026 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty five thousand eight hundred seventy?six (35,876) procedures with R3 20 degree XLPE Liners have been performed in Australia between 04-Dec-2006 and 20-Feb-2026. ;The mean cumulative revision rates for the R3 20 degree XLPE Liners were in line with the class across 18 years of follow-up based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.1% (1.9%¿2.2%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.3%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿2.9%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.2%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.2% (3.1%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.5% (3.3%¿3.7%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 3.7% (3.5%¿3.9%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 3.9% (3.7%¿4.1%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 4.1% (3.9%¿4.3%) vs 4.4% (4.4%¿4.5%) of the class.;-At 10th postoperative year: 4.2% (4.0%¿4.5%) vs 4.8% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 4.4% (4.1%¿4.7%) vs 5.1% (5.1%¿5.2%) of the class.;-At 12th postoperative year: 4.6% (4.3%¿4.9%) vs 5.6% (5.5%¿5.6%) of the class.;-At 13th postoperative year: 4.8% (4.5%¿5.2%) vs 6.0% (5.9%¿6.1%) of the class.;-At 14th postoperative year: 5.0% (4.7%¿5.4%) vs 6.4% (6.3%¿6.5%) of the class.;-At 15th postoperative year: 5.1% (4.8%¿5.5%) vs 6.9% (6.8%¿6.9%) of the class.;-At 16th postoperative year: 5.2% (4.8%¿5.6%) vs 7.4% (7.3%¿7.5%) of the class.;-At 17th postoperative year: 5.3% (4.9%¿5.8%) vs 7.8% (7.7%¿7.9%) of the class.;-At 18th postoperative year: 5.3% (4.9%¿5.8%) vs 8.3% (8.2%¿8.4%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279076-1-L325,,,4/16/2026,SPECTRON EF Hip System,SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 1,71312111, ,71312111, ,03596010195562,K970351,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral stem reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, three hundred and thirty-four (334) hips were later revised due to the following reasons: twenty-nine (29) hips due to fracture, one hundred and sixty-two (162) hips due to loosening, sixty-two (62) hips due to infection, fifty-one (51) hips due to prosthesis dislocation, fifteen (15) hips due to lysis, three (3) hips due to instability, one (1) hip due to malposition, one (1) hip due to implant breakage ¿ stem, two (2) hips due to metal related pathology, four (4) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, one (1) hip due to incorrect sizing, and one (1) hip due to other- unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Mar-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the SPECTRON EF Hip System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of four thousand three hundred and fifty-two (4,352) procedures with SPECTRON EF CoCr High Offset stems have been performed in Australia between 02-Sep-1999 and 28-Mar-2025. ;;The cumulative revision rates for the SPECTRON EF High Offset system were lower or in line with the class at 1-6 years. At later points, the cumulative revision rates for SPECTRON EF High Offset system were higher than the class as shown by non-overlapping confidence intervals.;The incidence of revision due to loosening, Wear Acetabular Insert, and lysis were higher in the SPECTRON EF Stem compared to class, however no statistical analysis can be performed to assess if this difference is statistically significant. Other reasons for revision were lower or in line with the class. The SPECTRON EF Hip System has been utilized with a variety of acetabular systems, including older systems coupled with Conventional Polyethylene (CPE) liners. Liners of CPE material had a higher wear rate compared to the currently used XLPE material. ;;The registry report provided further stratification of the 334 revisions based on the bearing surface used in combination with SPECTRON EF High Offset stems. When compared to the class average revisions per 100 observed component years (0.71, CI: 0.64, 0.79), the combinations performing worse than the class average are ceramic/non XLPE (1.63, CI: 0.84, 2.84), metal/metal (2.92, CI: 0.35, 10.55), metal/non XLPE (1.24, CI: 1.02, 1.49), ceramicised metal/non XLPE (1.39, CI: 0.66, 2.55), ceramicised metal/XLPE (0.78, CI: 0.63, 0.96) and ¿unknown¿ (0.80, CI: 0.02, 4.46). The combinations involving CPE increase the revision rate of the SPECTRON EF CoCr High Offset data. CPE is no longer offered in standard acetabular liners, where previously available. Additionally, the revisions per 100 observed years of the metal-on-metal combination may not be statistically significantly higher when compared to all Other Total Conventional Hip class (0.71, CI: 0.64, 0.79) when based on overlapping confidence intervals, but the revision rate is much higher. It is well documented that both metal-on-metal and bearing surfaces containing conventional polyethylene combinations have inherently higher revision rates due to increased particle debris and wear rates in primary total hip arthroplasties. Smith & Nephew, Inc. no longer sells conventional polyethylene or metal liners for use in total hip arthroplasty.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.5% (1.2%¿1.9%) vs 1.8% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.0% (1.6%¿2.5%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.2%¿3.2%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.5%¿3.5%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.5% (3.0%¿4.2%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 4.0% (3.4%¿4.6%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.5% (3.9%¿5.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.9% (4.3%¿5.6%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.8% (5.1%¿6.6%) vs 4.4% (4.3%¿4.5%) of the class.;-At 10th postoperative year: 6.5% (5.7%¿7.3%) vs 4.7% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 7.3% (6.4%¿8.2%) vs 5.1% (5.0%¿5.2%) of the class.;-At 12th postoperative year: 8.2% (7.3%¿9.2%) vs 5.5% (5.4%¿5.6%) of the class.;-At 13th postoperative year: 9.2% (8.2%¿10.4%) vs 5.9% (5.8%¿6.0%) of the class.;-At 14th postoperative year: 9.9% (8.8%¿11.1%) vs 6.3% (6.3%¿6.4%) of the class.;-At 15th postoperative year: 10.3% (9.2%¿11.6%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 11.0% (9.8%¿12.3%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 11.5% (10.3%¿12.9%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 11.8% (10.5%¿13.2%) vs 8.2% (8.1%¿8.3%) of the class.;-At 19th postoperative year: 12.4% (11.0%¿14.0%) vs 8.7% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 12.9% (11.3%¿14.6%) vs 9.2% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 14.4% (12.4%¿16.6%) vs 9.7% (9.5%¿9.9%) of the class.;-At 22nd postoperative year: 14.7% (12.7%¿17.1%) vs 10.2% (10.0%¿10.4%) of the class.;-At 23rd postoperative year: 14.7% (12.7%¿17.1%) vs 10.6% (10.4%¿10.8%) of the class.;-At 24th postoperative year: 14.7% (12.7%¿17.1%) vs 11.2% (10.9%¿11.5%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279076-1-L326,,,4/16/2026,SPECTRON EF Hip System,SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 1,71312111, ,71312111, ,03596010195562,K970351,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral stem reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, three hundred and thirty-four (334) hips were later revised due to the following reasons: twenty-nine (29) hips due to fracture, one hundred and sixty-two (162) hips due to loosening, sixty-two (62) hips due to infection, fifty-one (51) hips due to prosthesis dislocation, fifteen (15) hips due to lysis, three (3) hips due to instability, one (1) hip due to malposition, one (1) hip due to implant breakage ¿ stem, two (2) hips due to metal related pathology, four (4) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, one (1) hip due to incorrect sizing, and one (1) hip due to other- unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Mar-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the SPECTRON EF Hip System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of four thousand three hundred and fifty-two (4,352) procedures with SPECTRON EF CoCr High Offset stems have been performed in Australia between 02-Sep-1999 and 28-Mar-2025. ;;The cumulative revision rates for the SPECTRON EF High Offset system were lower or in line with the class at 1-6 years. At later points, the cumulative revision rates for SPECTRON EF High Offset system were higher than the class as shown by non-overlapping confidence intervals.;The incidence of revision due to loosening, Wear Acetabular Insert, and lysis were higher in the SPECTRON EF Stem compared to class, however no statistical analysis can be performed to assess if this difference is statistically significant. Other reasons for revision were lower or in line with the class. The SPECTRON EF Hip System has been utilized with a variety of acetabular systems, including older systems coupled with Conventional Polyethylene (CPE) liners. Liners of CPE material had a higher wear rate compared to the currently used XLPE material. ;;The registry report provided further stratification of the 334 revisions based on the bearing surface used in combination with SPECTRON EF High Offset stems. When compared to the class average revisions per 100 observed component years (0.71, CI: 0.64, 0.79), the combinations performing worse than the class average are ceramic/non XLPE (1.63, CI: 0.84, 2.84), metal/metal (2.92, CI: 0.35, 10.55), metal/non XLPE (1.24, CI: 1.02, 1.49), ceramicised metal/non XLPE (1.39, CI: 0.66, 2.55), ceramicised metal/XLPE (0.78, CI: 0.63, 0.96) and ¿unknown¿ (0.80, CI: 0.02, 4.46). The combinations involving CPE increase the revision rate of the SPECTRON EF CoCr High Offset data. CPE is no longer offered in standard acetabular liners, where previously available. Additionally, the revisions per 100 observed years of the metal-on-metal combination may not be statistically significantly higher when compared to all Other Total Conventional Hip class (0.71, CI: 0.64, 0.79) when based on overlapping confidence intervals, but the revision rate is much higher. It is well documented that both metal-on-metal and bearing surfaces containing conventional polyethylene combinations have inherently higher revision rates due to increased particle debris and wear rates in primary total hip arthroplasties. Smith & Nephew, Inc. no longer sells conventional polyethylene or metal liners for use in total hip arthroplasty.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.5% (1.2%¿1.9%) vs 1.8% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.0% (1.6%¿2.5%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.2%¿3.2%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.5%¿3.5%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.5% (3.0%¿4.2%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 4.0% (3.4%¿4.6%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.5% (3.9%¿5.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.9% (4.3%¿5.6%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.8% (5.1%¿6.6%) vs 4.4% (4.3%¿4.5%) of the class.;-At 10th postoperative year: 6.5% (5.7%¿7.3%) vs 4.7% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 7.3% (6.4%¿8.2%) vs 5.1% (5.0%¿5.2%) of the class.;-At 12th postoperative year: 8.2% (7.3%¿9.2%) vs 5.5% (5.4%¿5.6%) of the class.;-At 13th postoperative year: 9.2% (8.2%¿10.4%) vs 5.9% (5.8%¿6.0%) of the class.;-At 14th postoperative year: 9.9% (8.8%¿11.1%) vs 6.3% (6.3%¿6.4%) of the class.;-At 15th postoperative year: 10.3% (9.2%¿11.6%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 11.0% (9.8%¿12.3%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 11.5% (10.3%¿12.9%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 11.8% (10.5%¿13.2%) vs 8.2% (8.1%¿8.3%) of the class.;-At 19th postoperative year: 12.4% (11.0%¿14.0%) vs 8.7% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 12.9% (11.3%¿14.6%) vs 9.2% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 14.4% (12.4%¿16.6%) vs 9.7% (9.5%¿9.9%) of the class.;-At 22nd postoperative year: 14.7% (12.7%¿17.1%) vs 10.2% (10.0%¿10.4%) of the class.;-At 23rd postoperative year: 14.7% (12.7%¿17.1%) vs 10.6% (10.4%¿10.8%) of the class.;-At 24th postoperative year: 14.7% (12.7%¿17.1%) vs 11.2% (10.9%¿11.5%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279076-1-L327,,,4/16/2026,SPECTRON EF Hip System,SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 1,71312111, ,71312111, ,03596010195562,K970351,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral stem reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, three hundred and thirty-four (334) hips were later revised due to the following reasons: twenty-nine (29) hips due to fracture, one hundred and sixty-two (162) hips due to loosening, sixty-two (62) hips due to infection, fifty-one (51) hips due to prosthesis dislocation, fifteen (15) hips due to lysis, three (3) hips due to instability, one (1) hip due to malposition, one (1) hip due to implant breakage ¿ stem, two (2) hips due to metal related pathology, four (4) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, one (1) hip due to incorrect sizing, and one (1) hip due to other- unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Mar-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the SPECTRON EF Hip System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of four thousand three hundred and fifty-two (4,352) procedures with SPECTRON EF CoCr High Offset stems have been performed in Australia between 02-Sep-1999 and 28-Mar-2025. ;;The cumulative revision rates for the SPECTRON EF High Offset system were lower or in line with the class at 1-6 years. At later points, the cumulative revision rates for SPECTRON EF High Offset system were higher than the class as shown by non-overlapping confidence intervals.;The incidence of revision due to loosening, Wear Acetabular Insert, and lysis were higher in the SPECTRON EF Stem compared to class, however no statistical analysis can be performed to assess if this difference is statistically significant. Other reasons for revision were lower or in line with the class. The SPECTRON EF Hip System has been utilized with a variety of acetabular systems, including older systems coupled with Conventional Polyethylene (CPE) liners. Liners of CPE material had a higher wear rate compared to the currently used XLPE material. ;;The registry report provided further stratification of the 334 revisions based on the bearing surface used in combination with SPECTRON EF High Offset stems. When compared to the class average revisions per 100 observed component years (0.71, CI: 0.64, 0.79), the combinations performing worse than the class average are ceramic/non XLPE (1.63, CI: 0.84, 2.84), metal/metal (2.92, CI: 0.35, 10.55), metal/non XLPE (1.24, CI: 1.02, 1.49), ceramicised metal/non XLPE (1.39, CI: 0.66, 2.55), ceramicised metal/XLPE (0.78, CI: 0.63, 0.96) and ¿unknown¿ (0.80, CI: 0.02, 4.46). The combinations involving CPE increase the revision rate of the SPECTRON EF CoCr High Offset data. CPE is no longer offered in standard acetabular liners, where previously available. Additionally, the revisions per 100 observed years of the metal-on-metal combination may not be statistically significantly higher when compared to all Other Total Conventional Hip class (0.71, CI: 0.64, 0.79) when based on overlapping confidence intervals, but the revision rate is much higher. It is well documented that both metal-on-metal and bearing surfaces containing conventional polyethylene combinations have inherently higher revision rates due to increased particle debris and wear rates in primary total hip arthroplasties. Smith & Nephew, Inc. no longer sells conventional polyethylene or metal liners for use in total hip arthroplasty.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.5% (1.2%¿1.9%) vs 1.8% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.0% (1.6%¿2.5%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.2%¿3.2%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.5%¿3.5%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.5% (3.0%¿4.2%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 4.0% (3.4%¿4.6%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.5% (3.9%¿5.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.9% (4.3%¿5.6%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.8% (5.1%¿6.6%) vs 4.4% (4.3%¿4.5%) of the class.;-At 10th postoperative year: 6.5% (5.7%¿7.3%) vs 4.7% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 7.3% (6.4%¿8.2%) vs 5.1% (5.0%¿5.2%) of the class.;-At 12th postoperative year: 8.2% (7.3%¿9.2%) vs 5.5% (5.4%¿5.6%) of the class.;-At 13th postoperative year: 9.2% (8.2%¿10.4%) vs 5.9% (5.8%¿6.0%) of the class.;-At 14th postoperative year: 9.9% (8.8%¿11.1%) vs 6.3% (6.3%¿6.4%) of the class.;-At 15th postoperative year: 10.3% (9.2%¿11.6%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 11.0% (9.8%¿12.3%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 11.5% (10.3%¿12.9%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 11.8% (10.5%¿13.2%) vs 8.2% (8.1%¿8.3%) of the class.;-At 19th postoperative year: 12.4% (11.0%¿14.0%) vs 8.7% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 12.9% (11.3%¿14.6%) vs 9.2% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 14.4% (12.4%¿16.6%) vs 9.7% (9.5%¿9.9%) of the class.;-At 22nd postoperative year: 14.7% (12.7%¿17.1%) vs 10.2% (10.0%¿10.4%) of the class.;-At 23rd postoperative year: 14.7% (12.7%¿17.1%) vs 10.6% (10.4%¿10.8%) of the class.;-At 24th postoperative year: 14.7% (12.7%¿17.1%) vs 11.2% (10.9%¿11.5%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279076-1-L328,,,4/16/2026,SPECTRON EF Hip System,SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 2,71312112, ,71312112, ,03596010195579,K970351,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral stem reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, three hundred and thirty-four (334) hips were later revised due to the following reasons: twenty-nine (29) hips due to fracture, one hundred and sixty-two (162) hips due to loosening, sixty-two (62) hips due to infection, fifty-one (51) hips due to prosthesis dislocation, fifteen (15) hips due to lysis, three (3) hips due to instability, one (1) hip due to malposition, one (1) hip due to implant breakage ¿ stem, two (2) hips due to metal related pathology, four (4) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, one (1) hip due to incorrect sizing, and one (1) hip due to other- unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Mar-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the SPECTRON EF Hip System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of four thousand three hundred and fifty-two (4,352) procedures with SPECTRON EF CoCr High Offset stems have been performed in Australia between 02-Sep-1999 and 28-Mar-2025. ;;The cumulative revision rates for the SPECTRON EF High Offset system were lower or in line with the class at 1-6 years. At later points, the cumulative revision rates for SPECTRON EF High Offset system were higher than the class as shown by non-overlapping confidence intervals.;The incidence of revision due to loosening, Wear Acetabular Insert, and lysis were higher in the SPECTRON EF Stem compared to class, however no statistical analysis can be performed to assess if this difference is statistically significant. Other reasons for revision were lower or in line with the class. The SPECTRON EF Hip System has been utilized with a variety of acetabular systems, including older systems coupled with Conventional Polyethylene (CPE) liners. Liners of CPE material had a higher wear rate compared to the currently used XLPE material. ;;The registry report provided further stratification of the 334 revisions based on the bearing surface used in combination with SPECTRON EF High Offset stems. When compared to the class average revisions per 100 observed component years (0.71, CI: 0.64, 0.79), the combinations performing worse than the class average are ceramic/non XLPE (1.63, CI: 0.84, 2.84), metal/metal (2.92, CI: 0.35, 10.55), metal/non XLPE (1.24, CI: 1.02, 1.49), ceramicised metal/non XLPE (1.39, CI: 0.66, 2.55), ceramicised metal/XLPE (0.78, CI: 0.63, 0.96) and ¿unknown¿ (0.80, CI: 0.02, 4.46). The combinations involving CPE increase the revision rate of the SPECTRON EF CoCr High Offset data. CPE is no longer offered in standard acetabular liners, where previously available. Additionally, the revisions per 100 observed years of the metal-on-metal combination may not be statistically significantly higher when compared to all Other Total Conventional Hip class (0.71, CI: 0.64, 0.79) when based on overlapping confidence intervals, but the revision rate is much higher. It is well documented that both metal-on-metal and bearing surfaces containing conventional polyethylene combinations have inherently higher revision rates due to increased particle debris and wear rates in primary total hip arthroplasties. Smith & Nephew, Inc. no longer sells conventional polyethylene or metal liners for use in total hip arthroplasty.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.5% (1.2%¿1.9%) vs 1.8% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.0% (1.6%¿2.5%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.2%¿3.2%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.5%¿3.5%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.5% (3.0%¿4.2%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 4.0% (3.4%¿4.6%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.5% (3.9%¿5.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.9% (4.3%¿5.6%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.8% (5.1%¿6.6%) vs 4.4% (4.3%¿4.5%) of the class.;-At 10th postoperative year: 6.5% (5.7%¿7.3%) vs 4.7% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 7.3% (6.4%¿8.2%) vs 5.1% (5.0%¿5.2%) of the class.;-At 12th postoperative year: 8.2% (7.3%¿9.2%) vs 5.5% (5.4%¿5.6%) of the class.;-At 13th postoperative year: 9.2% (8.2%¿10.4%) vs 5.9% (5.8%¿6.0%) of the class.;-At 14th postoperative year: 9.9% (8.8%¿11.1%) vs 6.3% (6.3%¿6.4%) of the class.;-At 15th postoperative year: 10.3% (9.2%¿11.6%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 11.0% (9.8%¿12.3%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 11.5% (10.3%¿12.9%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 11.8% (10.5%¿13.2%) vs 8.2% (8.1%¿8.3%) of the class.;-At 19th postoperative year: 12.4% (11.0%¿14.0%) vs 8.7% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 12.9% (11.3%¿14.6%) vs 9.2% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 14.4% (12.4%¿16.6%) vs 9.7% (9.5%¿9.9%) of the class.;-At 22nd postoperative year: 14.7% (12.7%¿17.1%) vs 10.2% (10.0%¿10.4%) of the class.;-At 23rd postoperative year: 14.7% (12.7%¿17.1%) vs 10.6% (10.4%¿10.8%) of the class.;-At 24th postoperative year: 14.7% (12.7%¿17.1%) vs 11.2% (10.9%¿11.5%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279076-1-L329,,,4/16/2026,SPECTRON EF Hip System,SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 2,71312112, ,71312112, ,03596010195579,K970351,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral stem reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, three hundred and thirty-four (334) hips were later revised due to the following reasons: twenty-nine (29) hips due to fracture, one hundred and sixty-two (162) hips due to loosening, sixty-two (62) hips due to infection, fifty-one (51) hips due to prosthesis dislocation, fifteen (15) hips due to lysis, three (3) hips due to instability, one (1) hip due to malposition, one (1) hip due to implant breakage ¿ stem, two (2) hips due to metal related pathology, four (4) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, one (1) hip due to incorrect sizing, and one (1) hip due to other- unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Mar-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the SPECTRON EF Hip System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of four thousand three hundred and fifty-two (4,352) procedures with SPECTRON EF CoCr High Offset stems have been performed in Australia between 02-Sep-1999 and 28-Mar-2025. ;;The cumulative revision rates for the SPECTRON EF High Offset system were lower or in line with the class at 1-6 years. At later points, the cumulative revision rates for SPECTRON EF High Offset system were higher than the class as shown by non-overlapping confidence intervals.;The incidence of revision due to loosening, Wear Acetabular Insert, and lysis were higher in the SPECTRON EF Stem compared to class, however no statistical analysis can be performed to assess if this difference is statistically significant. Other reasons for revision were lower or in line with the class. The SPECTRON EF Hip System has been utilized with a variety of acetabular systems, including older systems coupled with Conventional Polyethylene (CPE) liners. Liners of CPE material had a higher wear rate compared to the currently used XLPE material. ;;The registry report provided further stratification of the 334 revisions based on the bearing surface used in combination with SPECTRON EF High Offset stems. When compared to the class average revisions per 100 observed component years (0.71, CI: 0.64, 0.79), the combinations performing worse than the class average are ceramic/non XLPE (1.63, CI: 0.84, 2.84), metal/metal (2.92, CI: 0.35, 10.55), metal/non XLPE (1.24, CI: 1.02, 1.49), ceramicised metal/non XLPE (1.39, CI: 0.66, 2.55), ceramicised metal/XLPE (0.78, CI: 0.63, 0.96) and ¿unknown¿ (0.80, CI: 0.02, 4.46). The combinations involving CPE increase the revision rate of the SPECTRON EF CoCr High Offset data. CPE is no longer offered in standard acetabular liners, where previously available. Additionally, the revisions per 100 observed years of the metal-on-metal combination may not be statistically significantly higher when compared to all Other Total Conventional Hip class (0.71, CI: 0.64, 0.79) when based on overlapping confidence intervals, but the revision rate is much higher. It is well documented that both metal-on-metal and bearing surfaces containing conventional polyethylene combinations have inherently higher revision rates due to increased particle debris and wear rates in primary total hip arthroplasties. Smith & Nephew, Inc. no longer sells conventional polyethylene or metal liners for use in total hip arthroplasty.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.5% (1.2%¿1.9%) vs 1.8% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.0% (1.6%¿2.5%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.2%¿3.2%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.5%¿3.5%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.5% (3.0%¿4.2%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 4.0% (3.4%¿4.6%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.5% (3.9%¿5.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.9% (4.3%¿5.6%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.8% (5.1%¿6.6%) vs 4.4% (4.3%¿4.5%) of the class.;-At 10th postoperative year: 6.5% (5.7%¿7.3%) vs 4.7% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 7.3% (6.4%¿8.2%) vs 5.1% (5.0%¿5.2%) of the class.;-At 12th postoperative year: 8.2% (7.3%¿9.2%) vs 5.5% (5.4%¿5.6%) of the class.;-At 13th postoperative year: 9.2% (8.2%¿10.4%) vs 5.9% (5.8%¿6.0%) of the class.;-At 14th postoperative year: 9.9% (8.8%¿11.1%) vs 6.3% (6.3%¿6.4%) of the class.;-At 15th postoperative year: 10.3% (9.2%¿11.6%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 11.0% (9.8%¿12.3%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 11.5% (10.3%¿12.9%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 11.8% (10.5%¿13.2%) vs 8.2% (8.1%¿8.3%) of the class.;-At 19th postoperative year: 12.4% (11.0%¿14.0%) vs 8.7% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 12.9% (11.3%¿14.6%) vs 9.2% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 14.4% (12.4%¿16.6%) vs 9.7% (9.5%¿9.9%) of the class.;-At 22nd postoperative year: 14.7% (12.7%¿17.1%) vs 10.2% (10.0%¿10.4%) of the class.;-At 23rd postoperative year: 14.7% (12.7%¿17.1%) vs 10.6% (10.4%¿10.8%) of the class.;-At 24th postoperative year: 14.7% (12.7%¿17.1%) vs 11.2% (10.9%¿11.5%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279076-1-L330,,,4/16/2026,SPECTRON EF Hip System,SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 2,71312112, ,71312112, ,03596010195579,K970351,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral stem reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, three hundred and thirty-four (334) hips were later revised due to the following reasons: twenty-nine (29) hips due to fracture, one hundred and sixty-two (162) hips due to loosening, sixty-two (62) hips due to infection, fifty-one (51) hips due to prosthesis dislocation, fifteen (15) hips due to lysis, three (3) hips due to instability, one (1) hip due to malposition, one (1) hip due to implant breakage ¿ stem, two (2) hips due to metal related pathology, four (4) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, one (1) hip due to incorrect sizing, and one (1) hip due to other- unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Mar-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the SPECTRON EF Hip System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of four thousand three hundred and fifty-two (4,352) procedures with SPECTRON EF CoCr High Offset stems have been performed in Australia between 02-Sep-1999 and 28-Mar-2025. ;;The cumulative revision rates for the SPECTRON EF High Offset system were lower or in line with the class at 1-6 years. At later points, the cumulative revision rates for SPECTRON EF High Offset system were higher than the class as shown by non-overlapping confidence intervals.;The incidence of revision due to loosening, Wear Acetabular Insert, and lysis were higher in the SPECTRON EF Stem compared to class, however no statistical analysis can be performed to assess if this difference is statistically significant. Other reasons for revision were lower or in line with the class. The SPECTRON EF Hip System has been utilized with a variety of acetabular systems, including older systems coupled with Conventional Polyethylene (CPE) liners. Liners of CPE material had a higher wear rate compared to the currently used XLPE material. ;;The registry report provided further stratification of the 334 revisions based on the bearing surface used in combination with SPECTRON EF High Offset stems. When compared to the class average revisions per 100 observed component years (0.71, CI: 0.64, 0.79), the combinations performing worse than the class average are ceramic/non XLPE (1.63, CI: 0.84, 2.84), metal/metal (2.92, CI: 0.35, 10.55), metal/non XLPE (1.24, CI: 1.02, 1.49), ceramicised metal/non XLPE (1.39, CI: 0.66, 2.55), ceramicised metal/XLPE (0.78, CI: 0.63, 0.96) and ¿unknown¿ (0.80, CI: 0.02, 4.46). The combinations involving CPE increase the revision rate of the SPECTRON EF CoCr High Offset data. CPE is no longer offered in standard acetabular liners, where previously available. Additionally, the revisions per 100 observed years of the metal-on-metal combination may not be statistically significantly higher when compared to all Other Total Conventional Hip class (0.71, CI: 0.64, 0.79) when based on overlapping confidence intervals, but the revision rate is much higher. It is well documented that both metal-on-metal and bearing surfaces containing conventional polyethylene combinations have inherently higher revision rates due to increased particle debris and wear rates in primary total hip arthroplasties. Smith & Nephew, Inc. no longer sells conventional polyethylene or metal liners for use in total hip arthroplasty.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.5% (1.2%¿1.9%) vs 1.8% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.0% (1.6%¿2.5%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.2%¿3.2%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.5%¿3.5%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.5% (3.0%¿4.2%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 4.0% (3.4%¿4.6%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.5% (3.9%¿5.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.9% (4.3%¿5.6%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.8% (5.1%¿6.6%) vs 4.4% (4.3%¿4.5%) of the class.;-At 10th postoperative year: 6.5% (5.7%¿7.3%) vs 4.7% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 7.3% (6.4%¿8.2%) vs 5.1% (5.0%¿5.2%) of the class.;-At 12th postoperative year: 8.2% (7.3%¿9.2%) vs 5.5% (5.4%¿5.6%) of the class.;-At 13th postoperative year: 9.2% (8.2%¿10.4%) vs 5.9% (5.8%¿6.0%) of the class.;-At 14th postoperative year: 9.9% (8.8%¿11.1%) vs 6.3% (6.3%¿6.4%) of the class.;-At 15th postoperative year: 10.3% (9.2%¿11.6%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 11.0% (9.8%¿12.3%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 11.5% (10.3%¿12.9%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 11.8% (10.5%¿13.2%) vs 8.2% (8.1%¿8.3%) of the class.;-At 19th postoperative year: 12.4% (11.0%¿14.0%) vs 8.7% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 12.9% (11.3%¿14.6%) vs 9.2% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 14.4% (12.4%¿16.6%) vs 9.7% (9.5%¿9.9%) of the class.;-At 22nd postoperative year: 14.7% (12.7%¿17.1%) vs 10.2% (10.0%¿10.4%) of the class.;-At 23rd postoperative year: 14.7% (12.7%¿17.1%) vs 10.6% (10.4%¿10.8%) of the class.;-At 24th postoperative year: 14.7% (12.7%¿17.1%) vs 11.2% (10.9%¿11.5%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279076-1-L331,,,4/16/2026,SPECTRON EF Hip System,SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 2,71312112, ,71312112, ,03596010195579,K970351,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral stem reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, three hundred and thirty-four (334) hips were later revised due to the following reasons: twenty-nine (29) hips due to fracture, one hundred and sixty-two (162) hips due to loosening, sixty-two (62) hips due to infection, fifty-one (51) hips due to prosthesis dislocation, fifteen (15) hips due to lysis, three (3) hips due to instability, one (1) hip due to malposition, one (1) hip due to implant breakage ¿ stem, two (2) hips due to metal related pathology, four (4) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, one (1) hip due to incorrect sizing, and one (1) hip due to other- unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Mar-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the SPECTRON EF Hip System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of four thousand three hundred and fifty-two (4,352) procedures with SPECTRON EF CoCr High Offset stems have been performed in Australia between 02-Sep-1999 and 28-Mar-2025. ;;The cumulative revision rates for the SPECTRON EF High Offset system were lower or in line with the class at 1-6 years. At later points, the cumulative revision rates for SPECTRON EF High Offset system were higher than the class as shown by non-overlapping confidence intervals.;The incidence of revision due to loosening, Wear Acetabular Insert, and lysis were higher in the SPECTRON EF Stem compared to class, however no statistical analysis can be performed to assess if this difference is statistically significant. Other reasons for revision were lower or in line with the class. The SPECTRON EF Hip System has been utilized with a variety of acetabular systems, including older systems coupled with Conventional Polyethylene (CPE) liners. Liners of CPE material had a higher wear rate compared to the currently used XLPE material. ;;The registry report provided further stratification of the 334 revisions based on the bearing surface used in combination with SPECTRON EF High Offset stems. When compared to the class average revisions per 100 observed component years (0.71, CI: 0.64, 0.79), the combinations performing worse than the class average are ceramic/non XLPE (1.63, CI: 0.84, 2.84), metal/metal (2.92, CI: 0.35, 10.55), metal/non XLPE (1.24, CI: 1.02, 1.49), ceramicised metal/non XLPE (1.39, CI: 0.66, 2.55), ceramicised metal/XLPE (0.78, CI: 0.63, 0.96) and ¿unknown¿ (0.80, CI: 0.02, 4.46). The combinations involving CPE increase the revision rate of the SPECTRON EF CoCr High Offset data. CPE is no longer offered in standard acetabular liners, where previously available. Additionally, the revisions per 100 observed years of the metal-on-metal combination may not be statistically significantly higher when compared to all Other Total Conventional Hip class (0.71, CI: 0.64, 0.79) when based on overlapping confidence intervals, but the revision rate is much higher. It is well documented that both metal-on-metal and bearing surfaces containing conventional polyethylene combinations have inherently higher revision rates due to increased particle debris and wear rates in primary total hip arthroplasties. Smith & Nephew, Inc. no longer sells conventional polyethylene or metal liners for use in total hip arthroplasty.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.5% (1.2%¿1.9%) vs 1.8% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.0% (1.6%¿2.5%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.2%¿3.2%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.5%¿3.5%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.5% (3.0%¿4.2%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 4.0% (3.4%¿4.6%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.5% (3.9%¿5.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.9% (4.3%¿5.6%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.8% (5.1%¿6.6%) vs 4.4% (4.3%¿4.5%) of the class.;-At 10th postoperative year: 6.5% (5.7%¿7.3%) vs 4.7% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 7.3% (6.4%¿8.2%) vs 5.1% (5.0%¿5.2%) of the class.;-At 12th postoperative year: 8.2% (7.3%¿9.2%) vs 5.5% (5.4%¿5.6%) of the class.;-At 13th postoperative year: 9.2% (8.2%¿10.4%) vs 5.9% (5.8%¿6.0%) of the class.;-At 14th postoperative year: 9.9% (8.8%¿11.1%) vs 6.3% (6.3%¿6.4%) of the class.;-At 15th postoperative year: 10.3% (9.2%¿11.6%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 11.0% (9.8%¿12.3%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 11.5% (10.3%¿12.9%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 11.8% (10.5%¿13.2%) vs 8.2% (8.1%¿8.3%) of the class.;-At 19th postoperative year: 12.4% (11.0%¿14.0%) vs 8.7% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 12.9% (11.3%¿14.6%) vs 9.2% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 14.4% (12.4%¿16.6%) vs 9.7% (9.5%¿9.9%) of the class.;-At 22nd postoperative year: 14.7% (12.7%¿17.1%) vs 10.2% (10.0%¿10.4%) of the class.;-At 23rd postoperative year: 14.7% (12.7%¿17.1%) vs 10.6% (10.4%¿10.8%) of the class.;-At 24th postoperative year: 14.7% (12.7%¿17.1%) vs 11.2% (10.9%¿11.5%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279076-1-L332,,,4/16/2026,SPECTRON EF Hip System,SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 2,71312112, ,71312112, ,03596010195579,K970351,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral stem reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, three hundred and thirty-four (334) hips were later revised due to the following reasons: twenty-nine (29) hips due to fracture, one hundred and sixty-two (162) hips due to loosening, sixty-two (62) hips due to infection, fifty-one (51) hips due to prosthesis dislocation, fifteen (15) hips due to lysis, three (3) hips due to instability, one (1) hip due to malposition, one (1) hip due to implant breakage ¿ stem, two (2) hips due to metal related pathology, four (4) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, one (1) hip due to incorrect sizing, and one (1) hip due to other- unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Mar-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the SPECTRON EF Hip System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of four thousand three hundred and fifty-two (4,352) procedures with SPECTRON EF CoCr High Offset stems have been performed in Australia between 02-Sep-1999 and 28-Mar-2025. ;;The cumulative revision rates for the SPECTRON EF High Offset system were lower or in line with the class at 1-6 years. At later points, the cumulative revision rates for SPECTRON EF High Offset system were higher than the class as shown by non-overlapping confidence intervals.;The incidence of revision due to loosening, Wear Acetabular Insert, and lysis were higher in the SPECTRON EF Stem compared to class, however no statistical analysis can be performed to assess if this difference is statistically significant. Other reasons for revision were lower or in line with the class. The SPECTRON EF Hip System has been utilized with a variety of acetabular systems, including older systems coupled with Conventional Polyethylene (CPE) liners. Liners of CPE material had a higher wear rate compared to the currently used XLPE material. ;;The registry report provided further stratification of the 334 revisions based on the bearing surface used in combination with SPECTRON EF High Offset stems. When compared to the class average revisions per 100 observed component years (0.71, CI: 0.64, 0.79), the combinations performing worse than the class average are ceramic/non XLPE (1.63, CI: 0.84, 2.84), metal/metal (2.92, CI: 0.35, 10.55), metal/non XLPE (1.24, CI: 1.02, 1.49), ceramicised metal/non XLPE (1.39, CI: 0.66, 2.55), ceramicised metal/XLPE (0.78, CI: 0.63, 0.96) and ¿unknown¿ (0.80, CI: 0.02, 4.46). The combinations involving CPE increase the revision rate of the SPECTRON EF CoCr High Offset data. CPE is no longer offered in standard acetabular liners, where previously available. Additionally, the revisions per 100 observed years of the metal-on-metal combination may not be statistically significantly higher when compared to all Other Total Conventional Hip class (0.71, CI: 0.64, 0.79) when based on overlapping confidence intervals, but the revision rate is much higher. It is well documented that both metal-on-metal and bearing surfaces containing conventional polyethylene combinations have inherently higher revision rates due to increased particle debris and wear rates in primary total hip arthroplasties. Smith & Nephew, Inc. no longer sells conventional polyethylene or metal liners for use in total hip arthroplasty.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.5% (1.2%¿1.9%) vs 1.8% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.0% (1.6%¿2.5%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.2%¿3.2%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.5%¿3.5%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.5% (3.0%¿4.2%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 4.0% (3.4%¿4.6%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.5% (3.9%¿5.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.9% (4.3%¿5.6%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.8% (5.1%¿6.6%) vs 4.4% (4.3%¿4.5%) of the class.;-At 10th postoperative year: 6.5% (5.7%¿7.3%) vs 4.7% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 7.3% (6.4%¿8.2%) vs 5.1% (5.0%¿5.2%) of the class.;-At 12th postoperative year: 8.2% (7.3%¿9.2%) vs 5.5% (5.4%¿5.6%) of the class.;-At 13th postoperative year: 9.2% (8.2%¿10.4%) vs 5.9% (5.8%¿6.0%) of the class.;-At 14th postoperative year: 9.9% (8.8%¿11.1%) vs 6.3% (6.3%¿6.4%) of the class.;-At 15th postoperative year: 10.3% (9.2%¿11.6%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 11.0% (9.8%¿12.3%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 11.5% (10.3%¿12.9%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 11.8% (10.5%¿13.2%) vs 8.2% (8.1%¿8.3%) of the class.;-At 19th postoperative year: 12.4% (11.0%¿14.0%) vs 8.7% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 12.9% (11.3%¿14.6%) vs 9.2% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 14.4% (12.4%¿16.6%) vs 9.7% (9.5%¿9.9%) of the class.;-At 22nd postoperative year: 14.7% (12.7%¿17.1%) vs 10.2% (10.0%¿10.4%) of the class.;-At 23rd postoperative year: 14.7% (12.7%¿17.1%) vs 10.6% (10.4%¿10.8%) of the class.;-At 24th postoperative year: 14.7% (12.7%¿17.1%) vs 11.2% (10.9%¿11.5%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279076-1-L333,,,4/16/2026,SPECTRON EF Hip System,SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 3,71312113, ,71312113, ,03596010195586,K970351,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral stem reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, three hundred and thirty-four (334) hips were later revised due to the following reasons: twenty-nine (29) hips due to fracture, one hundred and sixty-two (162) hips due to loosening, sixty-two (62) hips due to infection, fifty-one (51) hips due to prosthesis dislocation, fifteen (15) hips due to lysis, three (3) hips due to instability, one (1) hip due to malposition, one (1) hip due to implant breakage ¿ stem, two (2) hips due to metal related pathology, four (4) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, one (1) hip due to incorrect sizing, and one (1) hip due to other- unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Mar-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the SPECTRON EF Hip System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of four thousand three hundred and fifty-two (4,352) procedures with SPECTRON EF CoCr High Offset stems have been performed in Australia between 02-Sep-1999 and 28-Mar-2025. ;;The cumulative revision rates for the SPECTRON EF High Offset system were lower or in line with the class at 1-6 years. At later points, the cumulative revision rates for SPECTRON EF High Offset system were higher than the class as shown by non-overlapping confidence intervals.;The incidence of revision due to loosening, Wear Acetabular Insert, and lysis were higher in the SPECTRON EF Stem compared to class, however no statistical analysis can be performed to assess if this difference is statistically significant. Other reasons for revision were lower or in line with the class. The SPECTRON EF Hip System has been utilized with a variety of acetabular systems, including older systems coupled with Conventional Polyethylene (CPE) liners. Liners of CPE material had a higher wear rate compared to the currently used XLPE material. ;;The registry report provided further stratification of the 334 revisions based on the bearing surface used in combination with SPECTRON EF High Offset stems. When compared to the class average revisions per 100 observed component years (0.71, CI: 0.64, 0.79), the combinations performing worse than the class average are ceramic/non XLPE (1.63, CI: 0.84, 2.84), metal/metal (2.92, CI: 0.35, 10.55), metal/non XLPE (1.24, CI: 1.02, 1.49), ceramicised metal/non XLPE (1.39, CI: 0.66, 2.55), ceramicised metal/XLPE (0.78, CI: 0.63, 0.96) and ¿unknown¿ (0.80, CI: 0.02, 4.46). The combinations involving CPE increase the revision rate of the SPECTRON EF CoCr High Offset data. CPE is no longer offered in standard acetabular liners, where previously available. Additionally, the revisions per 100 observed years of the metal-on-metal combination may not be statistically significantly higher when compared to all Other Total Conventional Hip class (0.71, CI: 0.64, 0.79) when based on overlapping confidence intervals, but the revision rate is much higher. It is well documented that both metal-on-metal and bearing surfaces containing conventional polyethylene combinations have inherently higher revision rates due to increased particle debris and wear rates in primary total hip arthroplasties. Smith & Nephew, Inc. no longer sells conventional polyethylene or metal liners for use in total hip arthroplasty.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.5% (1.2%¿1.9%) vs 1.8% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.0% (1.6%¿2.5%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.2%¿3.2%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.5%¿3.5%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.5% (3.0%¿4.2%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 4.0% (3.4%¿4.6%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.5% (3.9%¿5.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.9% (4.3%¿5.6%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.8% (5.1%¿6.6%) vs 4.4% (4.3%¿4.5%) of the class.;-At 10th postoperative year: 6.5% (5.7%¿7.3%) vs 4.7% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 7.3% (6.4%¿8.2%) vs 5.1% (5.0%¿5.2%) of the class.;-At 12th postoperative year: 8.2% (7.3%¿9.2%) vs 5.5% (5.4%¿5.6%) of the class.;-At 13th postoperative year: 9.2% (8.2%¿10.4%) vs 5.9% (5.8%¿6.0%) of the class.;-At 14th postoperative year: 9.9% (8.8%¿11.1%) vs 6.3% (6.3%¿6.4%) of the class.;-At 15th postoperative year: 10.3% (9.2%¿11.6%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 11.0% (9.8%¿12.3%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 11.5% (10.3%¿12.9%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 11.8% (10.5%¿13.2%) vs 8.2% (8.1%¿8.3%) of the class.;-At 19th postoperative year: 12.4% (11.0%¿14.0%) vs 8.7% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 12.9% (11.3%¿14.6%) vs 9.2% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 14.4% (12.4%¿16.6%) vs 9.7% (9.5%¿9.9%) of the class.;-At 22nd postoperative year: 14.7% (12.7%¿17.1%) vs 10.2% (10.0%¿10.4%) of the class.;-At 23rd postoperative year: 14.7% (12.7%¿17.1%) vs 10.6% (10.4%¿10.8%) of the class.;-At 24th postoperative year: 14.7% (12.7%¿17.1%) vs 11.2% (10.9%¿11.5%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279076-1-L334,,,4/16/2026,SPECTRON EF Hip System,SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 3,71312113, ,71312113, ,03596010195586,K970351,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral stem reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of four thousand three hundred and fifty-two (4,352) hips underwent primary THA procedures between 02-Sep-1999 and 28-Mar-2025, using a SPECTRON EF CoCr High Offset stem. From these, three hundred and thirty-four (334) hips were later revised due to the following reasons: twenty-nine (29) hips due to fracture, one hundred and sixty-two (162) hips due to loosening, sixty-two (62) hips due to infection, fifty-one (51) hips due to prosthesis dislocation, fifteen (15) hips due to lysis, three (3) hips due to instability, one (1) hip due to malposition, one (1) hip due to implant breakage ¿ stem, two (2) hips due to metal related pathology, four (4) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, one (1) hip due to incorrect sizing, and one (1) hip due to other- unknown reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry data: Implantations conducted between 02-Sep-1999 and 28-Mar-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the SPECTRON EF Hip System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of four thousand three hundred and fifty-two (4,352) procedures with SPECTRON EF CoCr High Offset stems have been performed in Australia between 02-Sep-1999 and 28-Mar-2025. ;;The cumulative revision rates for the SPECTRON EF High Offset system were lower or in line with the class at 1-6 years. At later points, the cumulative revision rates for SPECTRON EF High Offset system were higher than the class as shown by non-overlapping confidence intervals.;The incidence of revision due to loosening, Wear Acetabular Insert, and lysis were higher in the SPECTRON EF Stem compared to class, however no statistical analysis can be performed to assess if this difference is statistically significant. Other reasons for revision were lower or in line with the class. The SPECTRON EF Hip System has been utilized with a variety of acetabular systems, including older systems coupled with Conventional Polyethylene (CPE) liners. Liners of CPE material had a higher wear rate compared to the currently used XLPE material. ;;The registry report provided further stratification of the 334 revisions based on the bearing surface used in combination with SPECTRON EF High Offset stems. When compared to the class average revisions per 100 observed component years (0.71, CI: 0.64, 0.79), the combinations performing worse than the class average are ceramic/non XLPE (1.63, CI: 0.84, 2.84), metal/metal (2.92, CI: 0.35, 10.55), metal/non XLPE (1.24, CI: 1.02, 1.49), ceramicised metal/non XLPE (1.39, CI: 0.66, 2.55), ceramicised metal/XLPE (0.78, CI: 0.63, 0.96) and ¿unknown¿ (0.80, CI: 0.02, 4.46). The combinations involving CPE increase the revision rate of the SPECTRON EF CoCr High Offset data. CPE is no longer offered in standard acetabular liners, where previously available. Additionally, the revisions per 100 observed years of the metal-on-metal combination may not be statistically significantly higher when compared to all Other Total Conventional Hip class (0.71, CI: 0.64, 0.79) when based on overlapping confidence intervals, but the revision rate is much higher. It is well documented that both metal-on-metal and bearing surfaces containing conventional polyethylene combinations have inherently higher revision rates due to increased particle debris and wear rates in primary total hip arthroplasties. Smith & Nephew, Inc. no longer sells conventional polyethylene or metal liners for use in total hip arthroplasty.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.5% (1.2%¿1.9%) vs 1.8% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.0% (1.6%¿2.5%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.2%¿3.2%) vs 2.6% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.5%¿3.5%) vs 2.9% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.5% (3.0%¿4.2%) vs 3.2% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 4.0% (3.4%¿4.6%) vs 3.5% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.5% (3.9%¿5.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.9% (4.3%¿5.6%) vs 4.1% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.8% (5.1%¿6.6%) vs 4.4% (4.3%¿4.5%) of the class.;-At 10th postoperative year: 6.5% (5.7%¿7.3%) vs 4.7% (4.7%¿4.8%) of the class.;-At 11th postoperative year: 7.3% (6.4%¿8.2%) vs 5.1% (5.0%¿5.2%) of the class.;-At 12th postoperative year: 8.2% (7.3%¿9.2%) vs 5.5% (5.4%¿5.6%) of the class.;-At 13th postoperative year: 9.2% (8.2%¿10.4%) vs 5.9% (5.8%¿6.0%) of the class.;-At 14th postoperative year: 9.9% (8.8%¿11.1%) vs 6.3% (6.3%¿6.4%) of the class.;-At 15th postoperative year: 10.3% (9.2%¿11.6%) vs 6.8% (6.7%¿6.9%) of the class.;-At 16th postoperative year: 11.0% (9.8%¿12.3%) vs 7.3% (7.2%¿7.4%) of the class.;-At 17th postoperative year: 11.5% (10.3%¿12.9%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 11.8% (10.5%¿13.2%) vs 8.2% (8.1%¿8.3%) of the class.;-At 19th postoperative year: 12.4% (11.0%¿14.0%) vs 8.7% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 12.9% (11.3%¿14.6%) vs 9.2% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 14.4% (12.4%¿16.6%) vs 9.7% (9.5%¿9.9%) of the class.;-At 22nd postoperative year: 14.7% (12.7%¿17.1%) vs 10.2% (10.0%¿10.4%) of the class.;-At 23rd postoperative year: 14.7% (12.7%¿17.1%) vs 10.6% (10.4%¿10.8%) of the class.;-At 24th postoperative year: 14.7% (12.7%¿17.1%) vs 11.2% (10.9%¿11.5%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279079-1-L7,,,4/16/2026,SPECTRON Hip Stem System,SPECTRON EF 12/14 TAPER LONG STRAIGHT 195MM MEDIUM,71312235,,71312235,,03596010386403,K970351,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred and eighteen (118) hips underwent primary THA procedures between 7-Dec-1999 and 7-Jan-2026, using a SPECTRON EF Revision Stem. From these, one (1) hip was revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral stem reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of one hundred and eighteen (118) hips underwent primary THA procedures between 7-Dec-1999 and 7-Jan-2026, using a SPECTRON EF Revision Stem. From these, seven (7) hips were later revised due to the following reasons: one (1) hip due to fracture, one (1) hip due to loosening, two (2) hips due to infection, two (2) hips due to prosthetic dislocation and one (1) hip due to lysis. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;Timeframe of Registry data: Implantations conducted between 7-Dec-1999 and 7-Jan-2026 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the SPECTRON Hip Stem system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one hundred and eighteen (118) primary THA procedures with SPECTRON EF Revision stems have been performed in Australia between 7-Dec-1999 and 7-Jan-2026. The cumulative revision rates for the SPECTRON EF revision stems were in line with the class at 1 and 3 years. At 2 and 4 years, the cumulative revision rates for SPECTRON EF Revision Stems were higher than the class as shown by non-overlapping confidence intervals. Overall, confidence intervals were wide due to the low volume of recorded implantations. ;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (0.5%-7.4%) vs 1.8% (1.7%-1.8%) of the class.;-At 2nd postoperative year: 6.0% (2.5%-14.0%) vs 2.2% (2.2%-2.2%) of the class.;-At 3rd postoperative year: 6.0% (2.5%-14.0%) vs 2.6% (2.5%-2.6%) of the class.;-At 4th postoperative year: 7.8% (3.5%-16.9%) vs 2.9% (2.8%-2.9%) of the class.;;It is further noted that the SPECTRON EF Revision Stem is predominantly utilized in complex primary THA procedures, which may be associated with an inherently higher risk of revision than standard primary THA. The proportion of hips with a more complex indications, including fractured neck of femur, failed internal fixation, and tumour, were higher in the SPECTRON EF Revision Stem cohort than in the class.;The incidence of revisions due to loosening, infection, prosthesis dislocation, and lysis was higher for the SPECTRON EF Revision Stem compared to the class. However, no statistical analysis was available for these specific revision indications, and therefore it cannot be determined whether the observed differences are statistically significant. Revision rates for other reported indications were lower than or comparable to the class.;It is also noted that the SPECTRON EF Hip System has historically been used with a variety of acetabular systems, including older systems utilizing conventional polyethylene (CPE) liners. Published evidence has demonstrated that, compared with cross?linked polyethylene (XLPE), CPE is associated with higher rates of revision related to loosening, lysis, and dislocation. Therefore, the use of CPE bearings may have contributed, at least in part, to the observed differences between the SPECTRON EF Revision Stem cohort and the class.;Infection is recognized as a complication associated with patient and procedure?related risk factors, including surgical environment and host susceptibility, and is not considered an inherent complication of the device.;In consideration of the differences in patient indications, case complexity, and bearing characteristics between the SPECTRON EF Revision Stem cohort and the class, the observed revision rates are considered to be influenced, at least in part, by these confounding factors. The identified reasons for revision are consistent with recognized complications of total hip arthroplasty and do not identify new or unexpected safety concerns. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279080-1-L455,,,5/19/2026,REFLECTION Acetabular System,REFLECTION XLPE 28MM INNER DIAMETER 20 DEGREE 46-48MM OUTER DIAMETER SIZE D,71333323, ,71333323, ,03596010455604,K002747, ,IN,"It was reported that, according to the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. This total includes REFLECTION XLPE Liner components approved for use in the United States under FDA product codes JDI and LPH. Of the five hundred sixty-nine (569) revision surgeries reported for these implants, four hundred sixty-five (465) revisions were associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI.;The AOANJRR report provides the complete list of reasons for revision for all 569 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code JDI. The reported reasons for revision include: one hundred and thirty-six (136) hips due to fracture, one hundred and forty-four (144) hips due to loosening, one hundred and ten (110) hips due to infection, one hundred and fifteen (115) hips due to prosthesis dislocation, nineteen (19) hips due to lysis, eight (8) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, five (5) hips due to malposition, six (6) hips due to implant breakage ¿ stem, three (3) hips due to metal related pathology, two (2) hips due to wear ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular, two (2) hips due to incorrect sizing, one (1) hip due to tumour and three (3) hips due to other-unknown reasons.;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 569 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Timeframe of Registry data: Implantations conducted between 05-Oct-2000 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirteen thousand nine hundred and seventy-one (13,971) primary THA procedures with REFLECTION XLPE acetabular liners have been performed in Australia between 05-Oct-2000 and 28-Jan-2025. The XLPE Liner variant group performed statistically significantly better at 24 years of follow-up, based on non-overlapping confidence intervals when compared to All Other THA reported in the AOANJRR. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.3% (1.1%-1.5%) vs 1.8% (1.7%-1.8%) of the class.;-At 2nd postoperative year: 1.5% (1.3%-1.7%) vs 2.2% (2.2%-2.3%) of the class.;-At 3rd postoperative year: 1.7% (1.5%-2.0%) vs 2.6% (2.5%-2.6%) of the class.;-At 4th postoperative year: 2.0% (1.8%-2.2%) vs 2.9% (2.8%-2.9%) of the class.;-At 5th postoperative year: 2.2% (1.9%-2.4%) vs 3.2% (3.1%-3.2%) of the class.;-At 6th postoperative year: 2.4% (2.1%-2.6%) vs 3.5% (3.4%-3.5%) of the class.;-At 7th postoperative year: 2.6% (2.3%-2.8%) vs 3.8% (3.7%-3.8%) of the class.;-At 8th postoperative year: 2.8% (2.5%-3.1%) vs 4.1% (4.0%-4.1%) of the class.;-At 9th postoperative year: 3.1% (2.8%-3.4%) vs 4.4% (4.4%-4.5%) of the class.;-At 10th postoperative year: 3.3% (3.0%-3.6%) vs 4.8% (4.7%-4.8%) of the class.;-At 11th postoperative year: 3.5% (3.2%-3.8%) vs 5.1% (5.1%-5.2%) of the class.;-At 12th postoperative year: 3.8% (3.5%-4.1%) vs 5.6% (5.5%-5.6%) of the class.;-At 13th postoperative year: 4.0% (3.7%-4.4%) vs 6.0% (5.9%-6.1%) of the class.;-At 14th postoperative year: 4.3% (3.9%-4.7%) vs 6.4% (6.3%-6.5%) of the class.;-At 15th postoperative year: 4.6% (4.2%-5.0%) vs 6.9% (6.8%-7.0%) of the class.;-At 16th postoperative year: 4.8% (4.4%-5.3%) vs 7.4% (7.3%-7.5%) of the class.;-At 17th postoperative year: 5.2% (4.7%-5.6%) vs 7.9% (7.7%-8.0%) of the class.;-At 18th postoperative year: 5.3% (4.8%-5.7%) vs 8.3% (8.2%-8.5%) of the class.;-At 19th postoperative year: 5.7% (5.2%-6.2%) vs 8.8% (8.7%-9.0%) of the class.;-At 20th postoperative year: 5.8% (5.3%-6.3%) vs 9.4% (9.2%-9.5%) of the class.;-At 21st postoperative year: 6.1% (5.5%-6.7%) vs 9.9% (9.7%-10.1%) of the class.;-At 22nd postoperative year: 6.3% (5.7%-7.0%) vs 10.4% (10.1%-10.6%) of the class.;-At 23rd postoperative year: 6.3% (5.7%-7.0%) vs 10.8% (10.6%-11.0%) of the class.;-At 24th postoperative year: 6.3% (5.7%-7.0%) vs 11.4% (11.1%-11.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279080-1-L456,,,5/19/2026,REFLECTION Acetabular System,REFLECTION XLPE 28MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333324, ,71333324, ,03596010455611,K002747, ,IN,"It was reported that, according to the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. This total includes REFLECTION XLPE Liner components approved for use in the United States under FDA product codes JDI and LPH. Of the five hundred sixty-nine (569) revision surgeries reported for these implants, four hundred sixty-five (465) revisions were associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI.;The AOANJRR report provides the complete list of reasons for revision for all 569 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code JDI. The reported reasons for revision include: one hundred and thirty-six (136) hips due to fracture, one hundred and forty-four (144) hips due to loosening, one hundred and ten (110) hips due to infection, one hundred and fifteen (115) hips due to prosthesis dislocation, nineteen (19) hips due to lysis, eight (8) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, five (5) hips due to malposition, six (6) hips due to implant breakage ¿ stem, three (3) hips due to metal related pathology, two (2) hips due to wear ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular, two (2) hips due to incorrect sizing, one (1) hip due to tumour and three (3) hips due to other-unknown reasons.;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 569 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Timeframe of Registry data: Implantations conducted between 05-Oct-2000 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirteen thousand nine hundred and seventy-one (13,971) primary THA procedures with REFLECTION XLPE acetabular liners have been performed in Australia between 05-Oct-2000 and 28-Jan-2025. The XLPE Liner variant group performed statistically significantly better at 24 years of follow-up, based on non-overlapping confidence intervals when compared to All Other THA reported in the AOANJRR. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.3% (1.1%-1.5%) vs 1.8% (1.7%-1.8%) of the class.;-At 2nd postoperative year: 1.5% (1.3%-1.7%) vs 2.2% (2.2%-2.3%) of the class.;-At 3rd postoperative year: 1.7% (1.5%-2.0%) vs 2.6% (2.5%-2.6%) of the class.;-At 4th postoperative year: 2.0% (1.8%-2.2%) vs 2.9% (2.8%-2.9%) of the class.;-At 5th postoperative year: 2.2% (1.9%-2.4%) vs 3.2% (3.1%-3.2%) of the class.;-At 6th postoperative year: 2.4% (2.1%-2.6%) vs 3.5% (3.4%-3.5%) of the class.;-At 7th postoperative year: 2.6% (2.3%-2.8%) vs 3.8% (3.7%-3.8%) of the class.;-At 8th postoperative year: 2.8% (2.5%-3.1%) vs 4.1% (4.0%-4.1%) of the class.;-At 9th postoperative year: 3.1% (2.8%-3.4%) vs 4.4% (4.4%-4.5%) of the class.;-At 10th postoperative year: 3.3% (3.0%-3.6%) vs 4.8% (4.7%-4.8%) of the class.;-At 11th postoperative year: 3.5% (3.2%-3.8%) vs 5.1% (5.1%-5.2%) of the class.;-At 12th postoperative year: 3.8% (3.5%-4.1%) vs 5.6% (5.5%-5.6%) of the class.;-At 13th postoperative year: 4.0% (3.7%-4.4%) vs 6.0% (5.9%-6.1%) of the class.;-At 14th postoperative year: 4.3% (3.9%-4.7%) vs 6.4% (6.3%-6.5%) of the class.;-At 15th postoperative year: 4.6% (4.2%-5.0%) vs 6.9% (6.8%-7.0%) of the class.;-At 16th postoperative year: 4.8% (4.4%-5.3%) vs 7.4% (7.3%-7.5%) of the class.;-At 17th postoperative year: 5.2% (4.7%-5.6%) vs 7.9% (7.7%-8.0%) of the class.;-At 18th postoperative year: 5.3% (4.8%-5.7%) vs 8.3% (8.2%-8.5%) of the class.;-At 19th postoperative year: 5.7% (5.2%-6.2%) vs 8.8% (8.7%-9.0%) of the class.;-At 20th postoperative year: 5.8% (5.3%-6.3%) vs 9.4% (9.2%-9.5%) of the class.;-At 21st postoperative year: 6.1% (5.5%-6.7%) vs 9.9% (9.7%-10.1%) of the class.;-At 22nd postoperative year: 6.3% (5.7%-7.0%) vs 10.4% (10.1%-10.6%) of the class.;-At 23rd postoperative year: 6.3% (5.7%-7.0%) vs 10.8% (10.6%-11.0%) of the class.;-At 24th postoperative year: 6.3% (5.7%-7.0%) vs 11.4% (11.1%-11.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279080-1-L457,,,5/19/2026,REFLECTION Acetabular System,REFLECTION XLPE 28MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333324, ,71333324, ,03596010455611,K002747, ,IN,"It was reported that, according to the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. This total includes REFLECTION XLPE Liner components approved for use in the United States under FDA product codes JDI and LPH. Of the five hundred sixty-nine (569) revision surgeries reported for these implants, four hundred sixty-five (465) revisions were associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI.;The AOANJRR report provides the complete list of reasons for revision for all 569 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code JDI. The reported reasons for revision include: one hundred and thirty-six (136) hips due to fracture, one hundred and forty-four (144) hips due to loosening, one hundred and ten (110) hips due to infection, one hundred and fifteen (115) hips due to prosthesis dislocation, nineteen (19) hips due to lysis, eight (8) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, five (5) hips due to malposition, six (6) hips due to implant breakage ¿ stem, three (3) hips due to metal related pathology, two (2) hips due to wear ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular, two (2) hips due to incorrect sizing, one (1) hip due to tumour and three (3) hips due to other-unknown reasons.;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 569 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Timeframe of Registry data: Implantations conducted between 05-Oct-2000 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirteen thousand nine hundred and seventy-one (13,971) primary THA procedures with REFLECTION XLPE acetabular liners have been performed in Australia between 05-Oct-2000 and 28-Jan-2025. The XLPE Liner variant group performed statistically significantly better at 24 years of follow-up, based on non-overlapping confidence intervals when compared to All Other THA reported in the AOANJRR. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.3% (1.1%-1.5%) vs 1.8% (1.7%-1.8%) of the class.;-At 2nd postoperative year: 1.5% (1.3%-1.7%) vs 2.2% (2.2%-2.3%) of the class.;-At 3rd postoperative year: 1.7% (1.5%-2.0%) vs 2.6% (2.5%-2.6%) of the class.;-At 4th postoperative year: 2.0% (1.8%-2.2%) vs 2.9% (2.8%-2.9%) of the class.;-At 5th postoperative year: 2.2% (1.9%-2.4%) vs 3.2% (3.1%-3.2%) of the class.;-At 6th postoperative year: 2.4% (2.1%-2.6%) vs 3.5% (3.4%-3.5%) of the class.;-At 7th postoperative year: 2.6% (2.3%-2.8%) vs 3.8% (3.7%-3.8%) of the class.;-At 8th postoperative year: 2.8% (2.5%-3.1%) vs 4.1% (4.0%-4.1%) of the class.;-At 9th postoperative year: 3.1% (2.8%-3.4%) vs 4.4% (4.4%-4.5%) of the class.;-At 10th postoperative year: 3.3% (3.0%-3.6%) vs 4.8% (4.7%-4.8%) of the class.;-At 11th postoperative year: 3.5% (3.2%-3.8%) vs 5.1% (5.1%-5.2%) of the class.;-At 12th postoperative year: 3.8% (3.5%-4.1%) vs 5.6% (5.5%-5.6%) of the class.;-At 13th postoperative year: 4.0% (3.7%-4.4%) vs 6.0% (5.9%-6.1%) of the class.;-At 14th postoperative year: 4.3% (3.9%-4.7%) vs 6.4% (6.3%-6.5%) of the class.;-At 15th postoperative year: 4.6% (4.2%-5.0%) vs 6.9% (6.8%-7.0%) of the class.;-At 16th postoperative year: 4.8% (4.4%-5.3%) vs 7.4% (7.3%-7.5%) of the class.;-At 17th postoperative year: 5.2% (4.7%-5.6%) vs 7.9% (7.7%-8.0%) of the class.;-At 18th postoperative year: 5.3% (4.8%-5.7%) vs 8.3% (8.2%-8.5%) of the class.;-At 19th postoperative year: 5.7% (5.2%-6.2%) vs 8.8% (8.7%-9.0%) of the class.;-At 20th postoperative year: 5.8% (5.3%-6.3%) vs 9.4% (9.2%-9.5%) of the class.;-At 21st postoperative year: 6.1% (5.5%-6.7%) vs 9.9% (9.7%-10.1%) of the class.;-At 22nd postoperative year: 6.3% (5.7%-7.0%) vs 10.4% (10.1%-10.6%) of the class.;-At 23rd postoperative year: 6.3% (5.7%-7.0%) vs 10.8% (10.6%-11.0%) of the class.;-At 24th postoperative year: 6.3% (5.7%-7.0%) vs 11.4% (11.1%-11.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279080-1-L458,,,5/19/2026,REFLECTION Acetabular System,REFLECTION XLPE 28MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333324, ,71333324, ,03596010455611,K002747, ,IN,"It was reported that, according to the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. This total includes REFLECTION XLPE Liner components approved for use in the United States under FDA product codes JDI and LPH. Of the five hundred sixty-nine (569) revision surgeries reported for these implants, four hundred sixty-five (465) revisions were associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI.;The AOANJRR report provides the complete list of reasons for revision for all 569 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code JDI. The reported reasons for revision include: one hundred and thirty-six (136) hips due to fracture, one hundred and forty-four (144) hips due to loosening, one hundred and ten (110) hips due to infection, one hundred and fifteen (115) hips due to prosthesis dislocation, nineteen (19) hips due to lysis, eight (8) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, five (5) hips due to malposition, six (6) hips due to implant breakage ¿ stem, three (3) hips due to metal related pathology, two (2) hips due to wear ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular, two (2) hips due to incorrect sizing, one (1) hip due to tumour and three (3) hips due to other-unknown reasons.;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 569 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Timeframe of Registry data: Implantations conducted between 05-Oct-2000 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirteen thousand nine hundred and seventy-one (13,971) primary THA procedures with REFLECTION XLPE acetabular liners have been performed in Australia between 05-Oct-2000 and 28-Jan-2025. The XLPE Liner variant group performed statistically significantly better at 24 years of follow-up, based on non-overlapping confidence intervals when compared to All Other THA reported in the AOANJRR. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.3% (1.1%-1.5%) vs 1.8% (1.7%-1.8%) of the class.;-At 2nd postoperative year: 1.5% (1.3%-1.7%) vs 2.2% (2.2%-2.3%) of the class.;-At 3rd postoperative year: 1.7% (1.5%-2.0%) vs 2.6% (2.5%-2.6%) of the class.;-At 4th postoperative year: 2.0% (1.8%-2.2%) vs 2.9% (2.8%-2.9%) of the class.;-At 5th postoperative year: 2.2% (1.9%-2.4%) vs 3.2% (3.1%-3.2%) of the class.;-At 6th postoperative year: 2.4% (2.1%-2.6%) vs 3.5% (3.4%-3.5%) of the class.;-At 7th postoperative year: 2.6% (2.3%-2.8%) vs 3.8% (3.7%-3.8%) of the class.;-At 8th postoperative year: 2.8% (2.5%-3.1%) vs 4.1% (4.0%-4.1%) of the class.;-At 9th postoperative year: 3.1% (2.8%-3.4%) vs 4.4% (4.4%-4.5%) of the class.;-At 10th postoperative year: 3.3% (3.0%-3.6%) vs 4.8% (4.7%-4.8%) of the class.;-At 11th postoperative year: 3.5% (3.2%-3.8%) vs 5.1% (5.1%-5.2%) of the class.;-At 12th postoperative year: 3.8% (3.5%-4.1%) vs 5.6% (5.5%-5.6%) of the class.;-At 13th postoperative year: 4.0% (3.7%-4.4%) vs 6.0% (5.9%-6.1%) of the class.;-At 14th postoperative year: 4.3% (3.9%-4.7%) vs 6.4% (6.3%-6.5%) of the class.;-At 15th postoperative year: 4.6% (4.2%-5.0%) vs 6.9% (6.8%-7.0%) of the class.;-At 16th postoperative year: 4.8% (4.4%-5.3%) vs 7.4% (7.3%-7.5%) of the class.;-At 17th postoperative year: 5.2% (4.7%-5.6%) vs 7.9% (7.7%-8.0%) of the class.;-At 18th postoperative year: 5.3% (4.8%-5.7%) vs 8.3% (8.2%-8.5%) of the class.;-At 19th postoperative year: 5.7% (5.2%-6.2%) vs 8.8% (8.7%-9.0%) of the class.;-At 20th postoperative year: 5.8% (5.3%-6.3%) vs 9.4% (9.2%-9.5%) of the class.;-At 21st postoperative year: 6.1% (5.5%-6.7%) vs 9.9% (9.7%-10.1%) of the class.;-At 22nd postoperative year: 6.3% (5.7%-7.0%) vs 10.4% (10.1%-10.6%) of the class.;-At 23rd postoperative year: 6.3% (5.7%-7.0%) vs 10.8% (10.6%-11.0%) of the class.;-At 24th postoperative year: 6.3% (5.7%-7.0%) vs 11.4% (11.1%-11.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279080-1-L459,,,5/19/2026,REFLECTION Acetabular System,REFLECTION XLPE 28MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETER SIZE G,71333326, ,71333326, ,03596010455635,K002747, ,IN,"It was reported that, according to the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. This total includes REFLECTION XLPE Liner components approved for use in the United States under FDA product codes JDI and LPH. Of the five hundred sixty-nine (569) revision surgeries reported for these implants, four hundred sixty-five (465) revisions were associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI.;The AOANJRR report provides the complete list of reasons for revision for all 569 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code JDI. The reported reasons for revision include: one hundred and thirty-six (136) hips due to fracture, one hundred and forty-four (144) hips due to loosening, one hundred and ten (110) hips due to infection, one hundred and fifteen (115) hips due to prosthesis dislocation, nineteen (19) hips due to lysis, eight (8) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, five (5) hips due to malposition, six (6) hips due to implant breakage ¿ stem, three (3) hips due to metal related pathology, two (2) hips due to wear ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular, two (2) hips due to incorrect sizing, one (1) hip due to tumour and three (3) hips due to other-unknown reasons.;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 569 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Timeframe of Registry data: Implantations conducted between 05-Oct-2000 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirteen thousand nine hundred and seventy-one (13,971) primary THA procedures with REFLECTION XLPE acetabular liners have been performed in Australia between 05-Oct-2000 and 28-Jan-2025. The XLPE Liner variant group performed statistically significantly better at 24 years of follow-up, based on non-overlapping confidence intervals when compared to All Other THA reported in the AOANJRR. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.3% (1.1%-1.5%) vs 1.8% (1.7%-1.8%) of the class.;-At 2nd postoperative year: 1.5% (1.3%-1.7%) vs 2.2% (2.2%-2.3%) of the class.;-At 3rd postoperative year: 1.7% (1.5%-2.0%) vs 2.6% (2.5%-2.6%) of the class.;-At 4th postoperative year: 2.0% (1.8%-2.2%) vs 2.9% (2.8%-2.9%) of the class.;-At 5th postoperative year: 2.2% (1.9%-2.4%) vs 3.2% (3.1%-3.2%) of the class.;-At 6th postoperative year: 2.4% (2.1%-2.6%) vs 3.5% (3.4%-3.5%) of the class.;-At 7th postoperative year: 2.6% (2.3%-2.8%) vs 3.8% (3.7%-3.8%) of the class.;-At 8th postoperative year: 2.8% (2.5%-3.1%) vs 4.1% (4.0%-4.1%) of the class.;-At 9th postoperative year: 3.1% (2.8%-3.4%) vs 4.4% (4.4%-4.5%) of the class.;-At 10th postoperative year: 3.3% (3.0%-3.6%) vs 4.8% (4.7%-4.8%) of the class.;-At 11th postoperative year: 3.5% (3.2%-3.8%) vs 5.1% (5.1%-5.2%) of the class.;-At 12th postoperative year: 3.8% (3.5%-4.1%) vs 5.6% (5.5%-5.6%) of the class.;-At 13th postoperative year: 4.0% (3.7%-4.4%) vs 6.0% (5.9%-6.1%) of the class.;-At 14th postoperative year: 4.3% (3.9%-4.7%) vs 6.4% (6.3%-6.5%) of the class.;-At 15th postoperative year: 4.6% (4.2%-5.0%) vs 6.9% (6.8%-7.0%) of the class.;-At 16th postoperative year: 4.8% (4.4%-5.3%) vs 7.4% (7.3%-7.5%) of the class.;-At 17th postoperative year: 5.2% (4.7%-5.6%) vs 7.9% (7.7%-8.0%) of the class.;-At 18th postoperative year: 5.3% (4.8%-5.7%) vs 8.3% (8.2%-8.5%) of the class.;-At 19th postoperative year: 5.7% (5.2%-6.2%) vs 8.8% (8.7%-9.0%) of the class.;-At 20th postoperative year: 5.8% (5.3%-6.3%) vs 9.4% (9.2%-9.5%) of the class.;-At 21st postoperative year: 6.1% (5.5%-6.7%) vs 9.9% (9.7%-10.1%) of the class.;-At 22nd postoperative year: 6.3% (5.7%-7.0%) vs 10.4% (10.1%-10.6%) of the class.;-At 23rd postoperative year: 6.3% (5.7%-7.0%) vs 10.8% (10.6%-11.0%) of the class.;-At 24th postoperative year: 6.3% (5.7%-7.0%) vs 11.4% (11.1%-11.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279080-1-L460,,,5/19/2026,REFLECTION Acetabular System,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333334, ,71333334, ,03596010455673,K002747, ,IN,"It was reported that, according to the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. This total includes REFLECTION XLPE Liner components approved for use in the United States under FDA product codes JDI and LPH. Of the five hundred sixty-nine (569) revision surgeries reported for these implants, four hundred sixty-five (465) revisions were associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI.;The AOANJRR report provides the complete list of reasons for revision for all 569 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code JDI. The reported reasons for revision include: one hundred and thirty-six (136) hips due to fracture, one hundred and forty-four (144) hips due to loosening, one hundred and ten (110) hips due to infection, one hundred and fifteen (115) hips due to prosthesis dislocation, nineteen (19) hips due to lysis, eight (8) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, five (5) hips due to malposition, six (6) hips due to implant breakage ¿ stem, three (3) hips due to metal related pathology, two (2) hips due to wear ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular, two (2) hips due to incorrect sizing, one (1) hip due to tumour and three (3) hips due to other-unknown reasons.;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 569 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Timeframe of Registry data: Implantations conducted between 05-Oct-2000 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirteen thousand nine hundred and seventy-one (13,971) primary THA procedures with REFLECTION XLPE acetabular liners have been performed in Australia between 05-Oct-2000 and 28-Jan-2025. The XLPE Liner variant group performed statistically significantly better at 24 years of follow-up, based on non-overlapping confidence intervals when compared to All Other THA reported in the AOANJRR. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.3% (1.1%-1.5%) vs 1.8% (1.7%-1.8%) of the class.;-At 2nd postoperative year: 1.5% (1.3%-1.7%) vs 2.2% (2.2%-2.3%) of the class.;-At 3rd postoperative year: 1.7% (1.5%-2.0%) vs 2.6% (2.5%-2.6%) of the class.;-At 4th postoperative year: 2.0% (1.8%-2.2%) vs 2.9% (2.8%-2.9%) of the class.;-At 5th postoperative year: 2.2% (1.9%-2.4%) vs 3.2% (3.1%-3.2%) of the class.;-At 6th postoperative year: 2.4% (2.1%-2.6%) vs 3.5% (3.4%-3.5%) of the class.;-At 7th postoperative year: 2.6% (2.3%-2.8%) vs 3.8% (3.7%-3.8%) of the class.;-At 8th postoperative year: 2.8% (2.5%-3.1%) vs 4.1% (4.0%-4.1%) of the class.;-At 9th postoperative year: 3.1% (2.8%-3.4%) vs 4.4% (4.4%-4.5%) of the class.;-At 10th postoperative year: 3.3% (3.0%-3.6%) vs 4.8% (4.7%-4.8%) of the class.;-At 11th postoperative year: 3.5% (3.2%-3.8%) vs 5.1% (5.1%-5.2%) of the class.;-At 12th postoperative year: 3.8% (3.5%-4.1%) vs 5.6% (5.5%-5.6%) of the class.;-At 13th postoperative year: 4.0% (3.7%-4.4%) vs 6.0% (5.9%-6.1%) of the class.;-At 14th postoperative year: 4.3% (3.9%-4.7%) vs 6.4% (6.3%-6.5%) of the class.;-At 15th postoperative year: 4.6% (4.2%-5.0%) vs 6.9% (6.8%-7.0%) of the class.;-At 16th postoperative year: 4.8% (4.4%-5.3%) vs 7.4% (7.3%-7.5%) of the class.;-At 17th postoperative year: 5.2% (4.7%-5.6%) vs 7.9% (7.7%-8.0%) of the class.;-At 18th postoperative year: 5.3% (4.8%-5.7%) vs 8.3% (8.2%-8.5%) of the class.;-At 19th postoperative year: 5.7% (5.2%-6.2%) vs 8.8% (8.7%-9.0%) of the class.;-At 20th postoperative year: 5.8% (5.3%-6.3%) vs 9.4% (9.2%-9.5%) of the class.;-At 21st postoperative year: 6.1% (5.5%-6.7%) vs 9.9% (9.7%-10.1%) of the class.;-At 22nd postoperative year: 6.3% (5.7%-7.0%) vs 10.4% (10.1%-10.6%) of the class.;-At 23rd postoperative year: 6.3% (5.7%-7.0%) vs 10.8% (10.6%-11.0%) of the class.;-At 24th postoperative year: 6.3% (5.7%-7.0%) vs 11.4% (11.1%-11.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279080-1-L461,,,5/19/2026,REFLECTION Acetabular System,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333334, ,71333334, ,03596010455673,K002747, ,IN,"It was reported that, according to the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. This total includes REFLECTION XLPE Liner components approved for use in the United States under FDA product codes JDI and LPH. Of the five hundred sixty-nine (569) revision surgeries reported for these implants, four hundred sixty-five (465) revisions were associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI.;The AOANJRR report provides the complete list of reasons for revision for all 569 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code JDI. The reported reasons for revision include: one hundred and thirty-six (136) hips due to fracture, one hundred and forty-four (144) hips due to loosening, one hundred and ten (110) hips due to infection, one hundred and fifteen (115) hips due to prosthesis dislocation, nineteen (19) hips due to lysis, eight (8) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, five (5) hips due to malposition, six (6) hips due to implant breakage ¿ stem, three (3) hips due to metal related pathology, two (2) hips due to wear ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular, two (2) hips due to incorrect sizing, one (1) hip due to tumour and three (3) hips due to other-unknown reasons.;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 569 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Timeframe of Registry data: Implantations conducted between 05-Oct-2000 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirteen thousand nine hundred and seventy-one (13,971) primary THA procedures with REFLECTION XLPE acetabular liners have been performed in Australia between 05-Oct-2000 and 28-Jan-2025. The XLPE Liner variant group performed statistically significantly better at 24 years of follow-up, based on non-overlapping confidence intervals when compared to All Other THA reported in the AOANJRR. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.3% (1.1%-1.5%) vs 1.8% (1.7%-1.8%) of the class.;-At 2nd postoperative year: 1.5% (1.3%-1.7%) vs 2.2% (2.2%-2.3%) of the class.;-At 3rd postoperative year: 1.7% (1.5%-2.0%) vs 2.6% (2.5%-2.6%) of the class.;-At 4th postoperative year: 2.0% (1.8%-2.2%) vs 2.9% (2.8%-2.9%) of the class.;-At 5th postoperative year: 2.2% (1.9%-2.4%) vs 3.2% (3.1%-3.2%) of the class.;-At 6th postoperative year: 2.4% (2.1%-2.6%) vs 3.5% (3.4%-3.5%) of the class.;-At 7th postoperative year: 2.6% (2.3%-2.8%) vs 3.8% (3.7%-3.8%) of the class.;-At 8th postoperative year: 2.8% (2.5%-3.1%) vs 4.1% (4.0%-4.1%) of the class.;-At 9th postoperative year: 3.1% (2.8%-3.4%) vs 4.4% (4.4%-4.5%) of the class.;-At 10th postoperative year: 3.3% (3.0%-3.6%) vs 4.8% (4.7%-4.8%) of the class.;-At 11th postoperative year: 3.5% (3.2%-3.8%) vs 5.1% (5.1%-5.2%) of the class.;-At 12th postoperative year: 3.8% (3.5%-4.1%) vs 5.6% (5.5%-5.6%) of the class.;-At 13th postoperative year: 4.0% (3.7%-4.4%) vs 6.0% (5.9%-6.1%) of the class.;-At 14th postoperative year: 4.3% (3.9%-4.7%) vs 6.4% (6.3%-6.5%) of the class.;-At 15th postoperative year: 4.6% (4.2%-5.0%) vs 6.9% (6.8%-7.0%) of the class.;-At 16th postoperative year: 4.8% (4.4%-5.3%) vs 7.4% (7.3%-7.5%) of the class.;-At 17th postoperative year: 5.2% (4.7%-5.6%) vs 7.9% (7.7%-8.0%) of the class.;-At 18th postoperative year: 5.3% (4.8%-5.7%) vs 8.3% (8.2%-8.5%) of the class.;-At 19th postoperative year: 5.7% (5.2%-6.2%) vs 8.8% (8.7%-9.0%) of the class.;-At 20th postoperative year: 5.8% (5.3%-6.3%) vs 9.4% (9.2%-9.5%) of the class.;-At 21st postoperative year: 6.1% (5.5%-6.7%) vs 9.9% (9.7%-10.1%) of the class.;-At 22nd postoperative year: 6.3% (5.7%-7.0%) vs 10.4% (10.1%-10.6%) of the class.;-At 23rd postoperative year: 6.3% (5.7%-7.0%) vs 10.8% (10.6%-11.0%) of the class.;-At 24th postoperative year: 6.3% (5.7%-7.0%) vs 11.4% (11.1%-11.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279080-1-L462,,,5/19/2026,REFLECTION Acetabular System,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333334, ,71333334, ,03596010455673,K002747, ,IN,"It was reported that, according to the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. This total includes REFLECTION XLPE Liner components approved for use in the United States under FDA product codes JDI and LPH. Of the five hundred sixty-nine (569) revision surgeries reported for these implants, four hundred sixty-five (465) revisions were associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI.;The AOANJRR report provides the complete list of reasons for revision for all 569 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code JDI. The reported reasons for revision include: one hundred and thirty-six (136) hips due to fracture, one hundred and forty-four (144) hips due to loosening, one hundred and ten (110) hips due to infection, one hundred and fifteen (115) hips due to prosthesis dislocation, nineteen (19) hips due to lysis, eight (8) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, five (5) hips due to malposition, six (6) hips due to implant breakage ¿ stem, three (3) hips due to metal related pathology, two (2) hips due to wear ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular, two (2) hips due to incorrect sizing, one (1) hip due to tumour and three (3) hips due to other-unknown reasons.;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 569 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Timeframe of Registry data: Implantations conducted between 05-Oct-2000 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirteen thousand nine hundred and seventy-one (13,971) primary THA procedures with REFLECTION XLPE acetabular liners have been performed in Australia between 05-Oct-2000 and 28-Jan-2025. The XLPE Liner variant group performed statistically significantly better at 24 years of follow-up, based on non-overlapping confidence intervals when compared to All Other THA reported in the AOANJRR. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.3% (1.1%-1.5%) vs 1.8% (1.7%-1.8%) of the class.;-At 2nd postoperative year: 1.5% (1.3%-1.7%) vs 2.2% (2.2%-2.3%) of the class.;-At 3rd postoperative year: 1.7% (1.5%-2.0%) vs 2.6% (2.5%-2.6%) of the class.;-At 4th postoperative year: 2.0% (1.8%-2.2%) vs 2.9% (2.8%-2.9%) of the class.;-At 5th postoperative year: 2.2% (1.9%-2.4%) vs 3.2% (3.1%-3.2%) of the class.;-At 6th postoperative year: 2.4% (2.1%-2.6%) vs 3.5% (3.4%-3.5%) of the class.;-At 7th postoperative year: 2.6% (2.3%-2.8%) vs 3.8% (3.7%-3.8%) of the class.;-At 8th postoperative year: 2.8% (2.5%-3.1%) vs 4.1% (4.0%-4.1%) of the class.;-At 9th postoperative year: 3.1% (2.8%-3.4%) vs 4.4% (4.4%-4.5%) of the class.;-At 10th postoperative year: 3.3% (3.0%-3.6%) vs 4.8% (4.7%-4.8%) of the class.;-At 11th postoperative year: 3.5% (3.2%-3.8%) vs 5.1% (5.1%-5.2%) of the class.;-At 12th postoperative year: 3.8% (3.5%-4.1%) vs 5.6% (5.5%-5.6%) of the class.;-At 13th postoperative year: 4.0% (3.7%-4.4%) vs 6.0% (5.9%-6.1%) of the class.;-At 14th postoperative year: 4.3% (3.9%-4.7%) vs 6.4% (6.3%-6.5%) of the class.;-At 15th postoperative year: 4.6% (4.2%-5.0%) vs 6.9% (6.8%-7.0%) of the class.;-At 16th postoperative year: 4.8% (4.4%-5.3%) vs 7.4% (7.3%-7.5%) of the class.;-At 17th postoperative year: 5.2% (4.7%-5.6%) vs 7.9% (7.7%-8.0%) of the class.;-At 18th postoperative year: 5.3% (4.8%-5.7%) vs 8.3% (8.2%-8.5%) of the class.;-At 19th postoperative year: 5.7% (5.2%-6.2%) vs 8.8% (8.7%-9.0%) of the class.;-At 20th postoperative year: 5.8% (5.3%-6.3%) vs 9.4% (9.2%-9.5%) of the class.;-At 21st postoperative year: 6.1% (5.5%-6.7%) vs 9.9% (9.7%-10.1%) of the class.;-At 22nd postoperative year: 6.3% (5.7%-7.0%) vs 10.4% (10.1%-10.6%) of the class.;-At 23rd postoperative year: 6.3% (5.7%-7.0%) vs 10.8% (10.6%-11.0%) of the class.;-At 24th postoperative year: 6.3% (5.7%-7.0%) vs 11.4% (11.1%-11.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279080-1-L463,,,5/19/2026,REFLECTION Acetabular System,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333335, ,71333335, ,03596010455680,K002747, ,IN,"It was reported that, according to the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. This total includes REFLECTION XLPE Liner components approved for use in the United States under FDA product codes JDI and LPH. Of the five hundred sixty-nine (569) revision surgeries reported for these implants, four hundred sixty-five (465) revisions were associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI.;The AOANJRR report provides the complete list of reasons for revision for all 569 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code JDI. The reported reasons for revision include: one hundred and thirty-six (136) hips due to fracture, one hundred and forty-four (144) hips due to loosening, one hundred and ten (110) hips due to infection, one hundred and fifteen (115) hips due to prosthesis dislocation, nineteen (19) hips due to lysis, eight (8) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, five (5) hips due to malposition, six (6) hips due to implant breakage ¿ stem, three (3) hips due to metal related pathology, two (2) hips due to wear ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular, two (2) hips due to incorrect sizing, one (1) hip due to tumour and three (3) hips due to other-unknown reasons.;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 569 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Timeframe of Registry data: Implantations conducted between 05-Oct-2000 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirteen thousand nine hundred and seventy-one (13,971) primary THA procedures with REFLECTION XLPE acetabular liners have been performed in Australia between 05-Oct-2000 and 28-Jan-2025. The XLPE Liner variant group performed statistically significantly better at 24 years of follow-up, based on non-overlapping confidence intervals when compared to All Other THA reported in the AOANJRR. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.3% (1.1%-1.5%) vs 1.8% (1.7%-1.8%) of the class.;-At 2nd postoperative year: 1.5% (1.3%-1.7%) vs 2.2% (2.2%-2.3%) of the class.;-At 3rd postoperative year: 1.7% (1.5%-2.0%) vs 2.6% (2.5%-2.6%) of the class.;-At 4th postoperative year: 2.0% (1.8%-2.2%) vs 2.9% (2.8%-2.9%) of the class.;-At 5th postoperative year: 2.2% (1.9%-2.4%) vs 3.2% (3.1%-3.2%) of the class.;-At 6th postoperative year: 2.4% (2.1%-2.6%) vs 3.5% (3.4%-3.5%) of the class.;-At 7th postoperative year: 2.6% (2.3%-2.8%) vs 3.8% (3.7%-3.8%) of the class.;-At 8th postoperative year: 2.8% (2.5%-3.1%) vs 4.1% (4.0%-4.1%) of the class.;-At 9th postoperative year: 3.1% (2.8%-3.4%) vs 4.4% (4.4%-4.5%) of the class.;-At 10th postoperative year: 3.3% (3.0%-3.6%) vs 4.8% (4.7%-4.8%) of the class.;-At 11th postoperative year: 3.5% (3.2%-3.8%) vs 5.1% (5.1%-5.2%) of the class.;-At 12th postoperative year: 3.8% (3.5%-4.1%) vs 5.6% (5.5%-5.6%) of the class.;-At 13th postoperative year: 4.0% (3.7%-4.4%) vs 6.0% (5.9%-6.1%) of the class.;-At 14th postoperative year: 4.3% (3.9%-4.7%) vs 6.4% (6.3%-6.5%) of the class.;-At 15th postoperative year: 4.6% (4.2%-5.0%) vs 6.9% (6.8%-7.0%) of the class.;-At 16th postoperative year: 4.8% (4.4%-5.3%) vs 7.4% (7.3%-7.5%) of the class.;-At 17th postoperative year: 5.2% (4.7%-5.6%) vs 7.9% (7.7%-8.0%) of the class.;-At 18th postoperative year: 5.3% (4.8%-5.7%) vs 8.3% (8.2%-8.5%) of the class.;-At 19th postoperative year: 5.7% (5.2%-6.2%) vs 8.8% (8.7%-9.0%) of the class.;-At 20th postoperative year: 5.8% (5.3%-6.3%) vs 9.4% (9.2%-9.5%) of the class.;-At 21st postoperative year: 6.1% (5.5%-6.7%) vs 9.9% (9.7%-10.1%) of the class.;-At 22nd postoperative year: 6.3% (5.7%-7.0%) vs 10.4% (10.1%-10.6%) of the class.;-At 23rd postoperative year: 6.3% (5.7%-7.0%) vs 10.8% (10.6%-11.0%) of the class.;-At 24th postoperative year: 6.3% (5.7%-7.0%) vs 11.4% (11.1%-11.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279080-1-L464,,,5/19/2026,REFLECTION Acetabular System,REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F,71333335, ,71333335, ,03596010455680,K002747, ,IN,"It was reported that, according to the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. This total includes REFLECTION XLPE Liner components approved for use in the United States under FDA product codes JDI and LPH. Of the five hundred sixty-nine (569) revision surgeries reported for these implants, four hundred sixty-five (465) revisions were associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI.;The AOANJRR report provides the complete list of reasons for revision for all 569 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code JDI. The reported reasons for revision include: one hundred and thirty-six (136) hips due to fracture, one hundred and forty-four (144) hips due to loosening, one hundred and ten (110) hips due to infection, one hundred and fifteen (115) hips due to prosthesis dislocation, nineteen (19) hips due to lysis, eight (8) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, five (5) hips due to malposition, six (6) hips due to implant breakage ¿ stem, three (3) hips due to metal related pathology, two (2) hips due to wear ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular, two (2) hips due to incorrect sizing, one (1) hip due to tumour and three (3) hips due to other-unknown reasons.;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 569 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Timeframe of Registry data: Implantations conducted between 05-Oct-2000 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirteen thousand nine hundred and seventy-one (13,971) primary THA procedures with REFLECTION XLPE acetabular liners have been performed in Australia between 05-Oct-2000 and 28-Jan-2025. The XLPE Liner variant group performed statistically significantly better at 24 years of follow-up, based on non-overlapping confidence intervals when compared to All Other THA reported in the AOANJRR. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.3% (1.1%-1.5%) vs 1.8% (1.7%-1.8%) of the class.;-At 2nd postoperative year: 1.5% (1.3%-1.7%) vs 2.2% (2.2%-2.3%) of the class.;-At 3rd postoperative year: 1.7% (1.5%-2.0%) vs 2.6% (2.5%-2.6%) of the class.;-At 4th postoperative year: 2.0% (1.8%-2.2%) vs 2.9% (2.8%-2.9%) of the class.;-At 5th postoperative year: 2.2% (1.9%-2.4%) vs 3.2% (3.1%-3.2%) of the class.;-At 6th postoperative year: 2.4% (2.1%-2.6%) vs 3.5% (3.4%-3.5%) of the class.;-At 7th postoperative year: 2.6% (2.3%-2.8%) vs 3.8% (3.7%-3.8%) of the class.;-At 8th postoperative year: 2.8% (2.5%-3.1%) vs 4.1% (4.0%-4.1%) of the class.;-At 9th postoperative year: 3.1% (2.8%-3.4%) vs 4.4% (4.4%-4.5%) of the class.;-At 10th postoperative year: 3.3% (3.0%-3.6%) vs 4.8% (4.7%-4.8%) of the class.;-At 11th postoperative year: 3.5% (3.2%-3.8%) vs 5.1% (5.1%-5.2%) of the class.;-At 12th postoperative year: 3.8% (3.5%-4.1%) vs 5.6% (5.5%-5.6%) of the class.;-At 13th postoperative year: 4.0% (3.7%-4.4%) vs 6.0% (5.9%-6.1%) of the class.;-At 14th postoperative year: 4.3% (3.9%-4.7%) vs 6.4% (6.3%-6.5%) of the class.;-At 15th postoperative year: 4.6% (4.2%-5.0%) vs 6.9% (6.8%-7.0%) of the class.;-At 16th postoperative year: 4.8% (4.4%-5.3%) vs 7.4% (7.3%-7.5%) of the class.;-At 17th postoperative year: 5.2% (4.7%-5.6%) vs 7.9% (7.7%-8.0%) of the class.;-At 18th postoperative year: 5.3% (4.8%-5.7%) vs 8.3% (8.2%-8.5%) of the class.;-At 19th postoperative year: 5.7% (5.2%-6.2%) vs 8.8% (8.7%-9.0%) of the class.;-At 20th postoperative year: 5.8% (5.3%-6.3%) vs 9.4% (9.2%-9.5%) of the class.;-At 21st postoperative year: 6.1% (5.5%-6.7%) vs 9.9% (9.7%-10.1%) of the class.;-At 22nd postoperative year: 6.3% (5.7%-7.0%) vs 10.4% (10.1%-10.6%) of the class.;-At 23rd postoperative year: 6.3% (5.7%-7.0%) vs 10.8% (10.6%-11.0%) of the class.;-At 24th postoperative year: 6.3% (5.7%-7.0%) vs 11.4% (11.1%-11.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279080-1-L465,,,5/19/2026,REFLECTION Acetabular System,REFLECTION XLPE 28MM INNER DIAMETER 0 DEGREE 50-52MM OUTER DIAMETER SIZE E,71333374, ,71333374, ,03596010455864,K002747, ,IN,"It was reported that, according to the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual acetabular liner reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of thirteen thousand nine hundred and seventy-one (13,971) hips underwent primary THA procedures between 05-Oct-2000 and 28-Jan-2025, using a REFLECTION XLPE Liner. This total includes REFLECTION XLPE Liner components approved for use in the United States under FDA product codes JDI and LPH. Of the five hundred sixty-nine (569) revision surgeries reported for these implants, four hundred sixty-five (465) revisions were associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI.;The AOANJRR report provides the complete list of reasons for revision for all 569 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code JDI. The reported reasons for revision include: one hundred and thirty-six (136) hips due to fracture, one hundred and forty-four (144) hips due to loosening, one hundred and ten (110) hips due to infection, one hundred and fifteen (115) hips due to prosthesis dislocation, nineteen (19) hips due to lysis, eight (8) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, five (5) hips due to malposition, six (6) hips due to implant breakage ¿ stem, three (3) hips due to metal related pathology, two (2) hips due to wear ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular insert, one (1) hip due to implant breakage ¿ acetabular, two (2) hips due to incorrect sizing, one (1) hip due to tumour and three (3) hips due to other-unknown reasons.;;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 569 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION XLPE Liner Component approved under FDA product code JDI. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Timeframe of Registry data: Implantations conducted between 05-Oct-2000 and 28-Jan-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of thirteen thousand nine hundred and seventy-one (13,971) primary THA procedures with REFLECTION XLPE acetabular liners have been performed in Australia between 05-Oct-2000 and 28-Jan-2025. The XLPE Liner variant group performed statistically significantly better at 24 years of follow-up, based on non-overlapping confidence intervals when compared to All Other THA reported in the AOANJRR. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.3% (1.1%-1.5%) vs 1.8% (1.7%-1.8%) of the class.;-At 2nd postoperative year: 1.5% (1.3%-1.7%) vs 2.2% (2.2%-2.3%) of the class.;-At 3rd postoperative year: 1.7% (1.5%-2.0%) vs 2.6% (2.5%-2.6%) of the class.;-At 4th postoperative year: 2.0% (1.8%-2.2%) vs 2.9% (2.8%-2.9%) of the class.;-At 5th postoperative year: 2.2% (1.9%-2.4%) vs 3.2% (3.1%-3.2%) of the class.;-At 6th postoperative year: 2.4% (2.1%-2.6%) vs 3.5% (3.4%-3.5%) of the class.;-At 7th postoperative year: 2.6% (2.3%-2.8%) vs 3.8% (3.7%-3.8%) of the class.;-At 8th postoperative year: 2.8% (2.5%-3.1%) vs 4.1% (4.0%-4.1%) of the class.;-At 9th postoperative year: 3.1% (2.8%-3.4%) vs 4.4% (4.4%-4.5%) of the class.;-At 10th postoperative year: 3.3% (3.0%-3.6%) vs 4.8% (4.7%-4.8%) of the class.;-At 11th postoperative year: 3.5% (3.2%-3.8%) vs 5.1% (5.1%-5.2%) of the class.;-At 12th postoperative year: 3.8% (3.5%-4.1%) vs 5.6% (5.5%-5.6%) of the class.;-At 13th postoperative year: 4.0% (3.7%-4.4%) vs 6.0% (5.9%-6.1%) of the class.;-At 14th postoperative year: 4.3% (3.9%-4.7%) vs 6.4% (6.3%-6.5%) of the class.;-At 15th postoperative year: 4.6% (4.2%-5.0%) vs 6.9% (6.8%-7.0%) of the class.;-At 16th postoperative year: 4.8% (4.4%-5.3%) vs 7.4% (7.3%-7.5%) of the class.;-At 17th postoperative year: 5.2% (4.7%-5.6%) vs 7.9% (7.7%-8.0%) of the class.;-At 18th postoperative year: 5.3% (4.8%-5.7%) vs 8.3% (8.2%-8.5%) of the class.;-At 19th postoperative year: 5.7% (5.2%-6.2%) vs 8.8% (8.7%-9.0%) of the class.;-At 20th postoperative year: 5.8% (5.3%-6.3%) vs 9.4% (9.2%-9.5%) of the class.;-At 21st postoperative year: 6.1% (5.5%-6.7%) vs 9.9% (9.7%-10.1%) of the class.;-At 22nd postoperative year: 6.3% (5.7%-7.0%) vs 10.4% (10.1%-10.6%) of the class.;-At 23rd postoperative year: 6.3% (5.7%-7.0%) vs 10.8% (10.6%-11.0%) of the class.;-At 24th postoperative year: 6.3% (5.7%-7.0%) vs 11.4% (11.1%-11.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279075-1-L83,,,6/5/2026,REFLECTION XLPE All-Poly Cup,REFLECTION ALL POLY XLPE 32MM INNER DIAMETER 49MM OUTER DIAMETER,71358034,,71358034,,03596010474247,K002747,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand nine hundred and forty-three (1,943) hips underwent primary THR between 25-Feb-2003 and 05-Mar-2026 in which a REFLECTION XLPE All-Poly Cup was implanted. Of these, one (1) hip was later revised due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand nine hundred and forty-three (1,943) hips underwent primary THR between 25-Feb-2003 and 05-Mar-2026 in which a REFLECTION XLPE All-Poly Cup was implanted. Of these, eighty-six (86) hips required revision due to the following reasons: seventeen (17) hips due to fracture, twenty-seven (27) due to loosening, twenty-three (23) due to infection, fourteen (14) due to prosthesis dislocation, one (1) due to lysis, one (1) due to instability, one (1) due to implant breakage of the stem, one (1) due to implant breakage of the acetabular component, one (1) due to wear of the acetabulum.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 25-Feb-2003 and 05-Mar-2026 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand nine hundred and forty-three (1,943) hips underwent primary THR in which a REFLECTION XLPE All-Poly Cup was implanted in Australia between 25-Feb-2003 and 05-Mar-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 2.1% (1.6%-2.9%) vs 1.8% (1.7%-1.8%) of the class;-At 2nd post-operative year: 2.6% (1.9%-3.4%) vs 2.2% (2.2%-2.2%) of the class;-At 3rd post-operative year: 2.6% (2.0%-3.5%) vs 2.6% (2.5%-2.6%) of the class;-At 4th post-operative year: 3.3% (2.6%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 3.6% (2.8%-4.6%) vs 3.2% (3.1%-3.2%) of the class;-At 6th post-operative year: 4.0% (3.2%-5.1%) vs 3.5% (3.4%-3.5%) of the class;-At 7th post-operative year: 4.2% (3.3%-5.3%) vs 3.8% (3.7%-3.8%) of the class;-At 8th post-operative year: 4.3% (3.4%-5.4%) vs 4.1% (4.0%-4.1%) of the class;-At 9th post-operative year: 4.5% (3.6%-5.7%) vs 4.4% (4.3%-4.5%) of the class;-At 10th post-operative year: 5.1% (4.1%-6.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 5.1% (4.1%-6.5%) vs 5.1% (5.0%-5.2%) of the class;-At 12th post-operative year: 5.3% (4.2%-6.7%) vs 5.5% (5.5%-5.6%) of the class;-At 13th post-operative year: 5.8% (4.6%-7.4%) vs 5.9% (5.9%-6.0%) of the class;-At 14th post-operative year: 6.1% (4.8%-7.6%) vs 6.4% (6.3%-6.4%) of the class;-At 15th post-operative year: 6.6% (5.2%-8.3%) vs 6.8% (6.7%-6.9%) of the class;-At 16th post-operative year: 6.6% (5.2%-8.3%) vs 7.3% (7.2%-7.4%) of the class;-At 17th post-operative year: 6.9% (5.4%-8.8%) vs 7.8% (7.7%-7.9%) of the class;-At 18th post-operative year: 7.4% (5.7%-9.6%) vs 8.2% (8.1%-8.4%) of the class;-At 19th post-operative year: 7.4% (5.7%-9.6%) vs 8.7% (8.6%-8.9%) of the class;-At 20th post-operative year: 7.4% (5.7%-9.6%) vs 9.2% (9.1%-9.4%) of the class;-At 21st post-operative year: 7.4% (5.7%-9.6%) vs 9.7% (9.6%-9.9%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the REFLECTION XLPE All-Poly Cup and the class, as determined by overlapping 95% confidence intervals across all evaluated postoperative years.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279075-1-L84,,,6/5/2026,REFLECTION XLPE All-Poly Cup,REFLECTION ALL POLY XLPE 32MM INNER DIAMETER 49MM OUTER DIAMETER,71358034,,71358034,,03596010474247,K002747,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand nine hundred and forty-three (1,943) hips underwent primary THR between 25-Feb-2003 and 05-Mar-2026 in which a REFLECTION XLPE All-Poly Cup was implanted. Of these, one (1) hip was later revised due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand nine hundred and forty-three (1,943) hips underwent primary THR between 25-Feb-2003 and 05-Mar-2026 in which a REFLECTION XLPE All-Poly Cup was implanted. Of these, eighty-six (86) hips required revision due to the following reasons: seventeen (17) hips due to fracture, twenty-seven (27) due to loosening, twenty-three (23) due to infection, fourteen (14) due to prosthesis dislocation, one (1) due to lysis, one (1) due to instability, one (1) due to implant breakage of the stem, one (1) due to implant breakage of the acetabular component, one (1) due to wear of the acetabulum.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 25-Feb-2003 and 05-Mar-2026 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand nine hundred and forty-three (1,943) hips underwent primary THR in which a REFLECTION XLPE All-Poly Cup was implanted in Australia between 25-Feb-2003 and 05-Mar-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 2.1% (1.6%-2.9%) vs 1.8% (1.7%-1.8%) of the class;-At 2nd post-operative year: 2.6% (1.9%-3.4%) vs 2.2% (2.2%-2.2%) of the class;-At 3rd post-operative year: 2.6% (2.0%-3.5%) vs 2.6% (2.5%-2.6%) of the class;-At 4th post-operative year: 3.3% (2.6%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 3.6% (2.8%-4.6%) vs 3.2% (3.1%-3.2%) of the class;-At 6th post-operative year: 4.0% (3.2%-5.1%) vs 3.5% (3.4%-3.5%) of the class;-At 7th post-operative year: 4.2% (3.3%-5.3%) vs 3.8% (3.7%-3.8%) of the class;-At 8th post-operative year: 4.3% (3.4%-5.4%) vs 4.1% (4.0%-4.1%) of the class;-At 9th post-operative year: 4.5% (3.6%-5.7%) vs 4.4% (4.3%-4.5%) of the class;-At 10th post-operative year: 5.1% (4.1%-6.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 5.1% (4.1%-6.5%) vs 5.1% (5.0%-5.2%) of the class;-At 12th post-operative year: 5.3% (4.2%-6.7%) vs 5.5% (5.5%-5.6%) of the class;-At 13th post-operative year: 5.8% (4.6%-7.4%) vs 5.9% (5.9%-6.0%) of the class;-At 14th post-operative year: 6.1% (4.8%-7.6%) vs 6.4% (6.3%-6.4%) of the class;-At 15th post-operative year: 6.6% (5.2%-8.3%) vs 6.8% (6.7%-6.9%) of the class;-At 16th post-operative year: 6.6% (5.2%-8.3%) vs 7.3% (7.2%-7.4%) of the class;-At 17th post-operative year: 6.9% (5.4%-8.8%) vs 7.8% (7.7%-7.9%) of the class;-At 18th post-operative year: 7.4% (5.7%-9.6%) vs 8.2% (8.1%-8.4%) of the class;-At 19th post-operative year: 7.4% (5.7%-9.6%) vs 8.7% (8.6%-8.9%) of the class;-At 20th post-operative year: 7.4% (5.7%-9.6%) vs 9.2% (9.1%-9.4%) of the class;-At 21st post-operative year: 7.4% (5.7%-9.6%) vs 9.7% (9.6%-9.9%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the REFLECTION XLPE All-Poly Cup and the class, as determined by overlapping 95% confidence intervals across all evaluated postoperative years.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279075-1-L85,,,6/5/2026,REFLECTION XLPE All-Poly Cup,REFLECTION ALL POLY XLPE 32MM INNER DIAMETER 55MM OUTER DIAMETER,71358036,,71358036,,03596010474261,K002747,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand nine hundred and forty-three (1,943) hips underwent primary THR between 25-Feb-2003 and 05-Mar-2026 in which a REFLECTION XLPE All-Poly Cup was implanted. Of these, one (1) hip was later revised due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand nine hundred and forty-three (1,943) hips underwent primary THR between 25-Feb-2003 and 05-Mar-2026 in which a REFLECTION XLPE All-Poly Cup was implanted. Of these, eighty-six (86) hips required revision due to the following reasons: seventeen (17) hips due to fracture, twenty-seven (27) due to loosening, twenty-three (23) due to infection, fourteen (14) due to prosthesis dislocation, one (1) due to lysis, one (1) due to instability, one (1) due to implant breakage of the stem, one (1) due to implant breakage of the acetabular component, one (1) due to wear of the acetabulum.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 25-Feb-2003 and 05-Mar-2026 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand nine hundred and forty-three (1,943) hips underwent primary THR in which a REFLECTION XLPE All-Poly Cup was implanted in Australia between 25-Feb-2003 and 05-Mar-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 2.1% (1.6%-2.9%) vs 1.8% (1.7%-1.8%) of the class;-At 2nd post-operative year: 2.6% (1.9%-3.4%) vs 2.2% (2.2%-2.2%) of the class;-At 3rd post-operative year: 2.6% (2.0%-3.5%) vs 2.6% (2.5%-2.6%) of the class;-At 4th post-operative year: 3.3% (2.6%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 3.6% (2.8%-4.6%) vs 3.2% (3.1%-3.2%) of the class;-At 6th post-operative year: 4.0% (3.2%-5.1%) vs 3.5% (3.4%-3.5%) of the class;-At 7th post-operative year: 4.2% (3.3%-5.3%) vs 3.8% (3.7%-3.8%) of the class;-At 8th post-operative year: 4.3% (3.4%-5.4%) vs 4.1% (4.0%-4.1%) of the class;-At 9th post-operative year: 4.5% (3.6%-5.7%) vs 4.4% (4.3%-4.5%) of the class;-At 10th post-operative year: 5.1% (4.1%-6.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 5.1% (4.1%-6.5%) vs 5.1% (5.0%-5.2%) of the class;-At 12th post-operative year: 5.3% (4.2%-6.7%) vs 5.5% (5.5%-5.6%) of the class;-At 13th post-operative year: 5.8% (4.6%-7.4%) vs 5.9% (5.9%-6.0%) of the class;-At 14th post-operative year: 6.1% (4.8%-7.6%) vs 6.4% (6.3%-6.4%) of the class;-At 15th post-operative year: 6.6% (5.2%-8.3%) vs 6.8% (6.7%-6.9%) of the class;-At 16th post-operative year: 6.6% (5.2%-8.3%) vs 7.3% (7.2%-7.4%) of the class;-At 17th post-operative year: 6.9% (5.4%-8.8%) vs 7.8% (7.7%-7.9%) of the class;-At 18th post-operative year: 7.4% (5.7%-9.6%) vs 8.2% (8.1%-8.4%) of the class;-At 19th post-operative year: 7.4% (5.7%-9.6%) vs 8.7% (8.6%-8.9%) of the class;-At 20th post-operative year: 7.4% (5.7%-9.6%) vs 9.2% (9.1%-9.4%) of the class;-At 21st post-operative year: 7.4% (5.7%-9.6%) vs 9.7% (9.6%-9.9%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the REFLECTION XLPE All-Poly Cup and the class, as determined by overlapping 95% confidence intervals across all evaluated postoperative years.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279075-1-L86,,,6/5/2026,REFLECTION XLPE All-Poly Cup,REFLECTION XLPE ALL POLY CUP 36MM INNER DIAMETER 52MM OUTER DIAMETER,71358065,,71358065,,03596010533173,K002747,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand nine hundred and forty-three (1,943) hips underwent primary THR between 25-Feb-2003 and 05-Mar-2026 in which a REFLECTION XLPE All-Poly Cup was implanted. Of these, one (1) hip was later revised due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand nine hundred and forty-three (1,943) hips underwent primary THR between 25-Feb-2003 and 05-Mar-2026 in which a REFLECTION XLPE All-Poly Cup was implanted. Of these, eighty-six (86) hips required revision due to the following reasons: seventeen (17) hips due to fracture, twenty-seven (27) due to loosening, twenty-three (23) due to infection, fourteen (14) due to prosthesis dislocation, one (1) due to lysis, one (1) due to instability, one (1) due to implant breakage of the stem, one (1) due to implant breakage of the acetabular component, one (1) due to wear of the acetabulum.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 25-Feb-2003 and 05-Mar-2026 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand nine hundred and forty-three (1,943) hips underwent primary THR in which a REFLECTION XLPE All-Poly Cup was implanted in Australia between 25-Feb-2003 and 05-Mar-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 2.1% (1.6%-2.9%) vs 1.8% (1.7%-1.8%) of the class;-At 2nd post-operative year: 2.6% (1.9%-3.4%) vs 2.2% (2.2%-2.2%) of the class;-At 3rd post-operative year: 2.6% (2.0%-3.5%) vs 2.6% (2.5%-2.6%) of the class;-At 4th post-operative year: 3.3% (2.6%-4.3%) vs 2.9% (2.8%-2.9%) of the class;-At 5th post-operative year: 3.6% (2.8%-4.6%) vs 3.2% (3.1%-3.2%) of the class;-At 6th post-operative year: 4.0% (3.2%-5.1%) vs 3.5% (3.4%-3.5%) of the class;-At 7th post-operative year: 4.2% (3.3%-5.3%) vs 3.8% (3.7%-3.8%) of the class;-At 8th post-operative year: 4.3% (3.4%-5.4%) vs 4.1% (4.0%-4.1%) of the class;-At 9th post-operative year: 4.5% (3.6%-5.7%) vs 4.4% (4.3%-4.5%) of the class;-At 10th post-operative year: 5.1% (4.1%-6.5%) vs 4.7% (4.7%-4.8%) of the class;-At 11th post-operative year: 5.1% (4.1%-6.5%) vs 5.1% (5.0%-5.2%) of the class;-At 12th post-operative year: 5.3% (4.2%-6.7%) vs 5.5% (5.5%-5.6%) of the class;-At 13th post-operative year: 5.8% (4.6%-7.4%) vs 5.9% (5.9%-6.0%) of the class;-At 14th post-operative year: 6.1% (4.8%-7.6%) vs 6.4% (6.3%-6.4%) of the class;-At 15th post-operative year: 6.6% (5.2%-8.3%) vs 6.8% (6.7%-6.9%) of the class;-At 16th post-operative year: 6.6% (5.2%-8.3%) vs 7.3% (7.2%-7.4%) of the class;-At 17th post-operative year: 6.9% (5.4%-8.8%) vs 7.8% (7.7%-7.9%) of the class;-At 18th post-operative year: 7.4% (5.7%-9.6%) vs 8.2% (8.1%-8.4%) of the class;-At 19th post-operative year: 7.4% (5.7%-9.6%) vs 8.7% (8.6%-8.9%) of the class;-At 20th post-operative year: 7.4% (5.7%-9.6%) vs 9.2% (9.1%-9.4%) of the class;-At 21st post-operative year: 7.4% (5.7%-9.6%) vs 9.7% (9.6%-9.9%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the REFLECTION XLPE All-Poly Cup and the class, as determined by overlapping 95% confidence intervals across all evaluated postoperative years.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279074-1-L12,,,6/5/2026,REFLECTION XLPE All-Poly Cup,REFLECTION XLPE ALL POLY CUP 36MM INNER DIAMETER 52MM OUTER DIAMETER,71358065,,71358065,,03596010533173,K002747,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of sixty-two (62) hips underwent revision THR between 24-Jul-2004 and 28-Nov-2025 in which a REFLECTION XLPE All-Poly Cup was implanted. Of these, one (1) hip was later re-revised due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each re-revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for re-revision. ","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of sixty-two (62) hips underwent revision THR between 24-Jul-2004 and 28-Nov-2025 in which a REFLECTION XLPE All-Poly Cup was implanted. Of these, thirteen (13) hips required re-revision due to the following reasons: two (2) hips due to prosthesis dislocation, two (2) due to loosening, five (5) due to infection, four (4) due to fracture.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for re-revision. ;Timeframe of Registry Data: Implantations conducted between 24-Jul-2004 and 28-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of sixty-two (62) hips underwent revision THR in which a REFLECTION XLPE All-Poly Cup was implanted in Australia between 24-Jul-2004 and 28-Nov-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 15.1% (8.2%-27.1%) vs 7.9% (7.4%-8.4%) of the class;-At 2nd post-operative year: 18.9% (10.9%-31.6%) vs 10.2% (9.7%-10.8%) of the class;-At 3rd post-operative year: 18.9% (10.9%-31.6%) vs 11.6% (11.0%-12.2%) of the class;-At 4th post-operative year: 23.3% (14.2%-36.9%) vs 12.7% (12.1%-13.4%) of the class;-At 5th post-operative year: 23.3% (14.2%-36.9%) vs 13.7% (13.0%-14.3%) of the class;-At 6th post-operative year: 23.3% (14.2%-36.9%) vs 14.6% (13.9%-15.3%) of the class;-At 7th post-operative year: 23.3% (14.2%-36.9%) vs 15.2% (14.5%-15.9%) of the class;-At 8th post-operative year: 23.3% (14.2%-36.9%) vs 15.9% (15.2%-16.7%) of the class;-At 9th post-operative year: 23.3% (14.2%-36.9%) vs 16.6% (15.9%-17.4%) of the class;-At 10th post-operative year: 23.3% (14.2%-36.9%) vs 17.2% (16.5%-18.0%) of the class;-At 11th post-operative year: 23.3% (14.2%-36.9%) vs 17.9% (17.1%-18.7%) of the class;By observing the cumulative re-revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the REFLECTION XLPE All-Poly Cup and the revision THR class for the 1st, 3rd, and 5th through 11th postoperative years, as determined by overlapping 95% confidence intervals. ;A statistically significant difference is observed only at the 2nd and 4th postoperative years, where the confidence intervals do not overlap, with the REFLECTION XLPE All-Poly Cup demonstrating higher revision rates than the class. It is important to note that, due to the low number of patients at risk in the REFLECTION All-Poly XLPE Cup group, confidence intervals are wide and the model may not be statistically strongly reliable. Additionally, this cohort demonstrates a higher proportion of re-revisions attributable to infection (38.5%) compared with the revision THA class (22.0%). Infection is a well-recognized postoperative complication that is typically influenced by patient-related and perioperative factors, rather than inherent device characteristics. Consequently, the elevated contribution of infection-related re-revisions may partly explain the observed increase in overall re-revision rates for this group.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00279074-1-L13,,,6/5/2026,REFLECTION XLPE All-Poly Cup,REFLECTION XLPE ALL POLY CUP 36MM INNER DIAMETER 55MM OUTER DIAMETER,71358066,,71358066,,03596010533166,K002747,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of sixty-two (62) hips underwent revision THR between 24-Jul-2004 and 28-Nov-2025 in which a REFLECTION XLPE All-Poly Cup was implanted. Of these, one (1) hip was later re-revised due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each re-revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for re-revision. ","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of sixty-two (62) hips underwent revision THR between 24-Jul-2004 and 28-Nov-2025 in which a REFLECTION XLPE All-Poly Cup was implanted. Of these, thirteen (13) hips required re-revision due to the following reasons: two (2) hips due to prosthesis dislocation, two (2) due to loosening, five (5) due to infection, four (4) due to fracture.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for re-revision. ;Timeframe of Registry Data: Implantations conducted between 24-Jul-2004 and 28-Nov-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of sixty-two (62) hips underwent revision THR in which a REFLECTION XLPE All-Poly Cup was implanted in Australia between 24-Jul-2004 and 28-Nov-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st post-operative year: 15.1% (8.2%-27.1%) vs 7.9% (7.4%-8.4%) of the class;-At 2nd post-operative year: 18.9% (10.9%-31.6%) vs 10.2% (9.7%-10.8%) of the class;-At 3rd post-operative year: 18.9% (10.9%-31.6%) vs 11.6% (11.0%-12.2%) of the class;-At 4th post-operative year: 23.3% (14.2%-36.9%) vs 12.7% (12.1%-13.4%) of the class;-At 5th post-operative year: 23.3% (14.2%-36.9%) vs 13.7% (13.0%-14.3%) of the class;-At 6th post-operative year: 23.3% (14.2%-36.9%) vs 14.6% (13.9%-15.3%) of the class;-At 7th post-operative year: 23.3% (14.2%-36.9%) vs 15.2% (14.5%-15.9%) of the class;-At 8th post-operative year: 23.3% (14.2%-36.9%) vs 15.9% (15.2%-16.7%) of the class;-At 9th post-operative year: 23.3% (14.2%-36.9%) vs 16.6% (15.9%-17.4%) of the class;-At 10th post-operative year: 23.3% (14.2%-36.9%) vs 17.2% (16.5%-18.0%) of the class;-At 11th post-operative year: 23.3% (14.2%-36.9%) vs 17.9% (17.1%-18.7%) of the class;By observing the cumulative re-revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the REFLECTION XLPE All-Poly Cup and the revision THR class for the 1st, 3rd, and 5th through 11th postoperative years, as determined by overlapping 95% confidence intervals. ;A statistically significant difference is observed only at the 2nd and 4th postoperative years, where the confidence intervals do not overlap, with the REFLECTION XLPE All-Poly Cup demonstrating higher revision rates than the class. It is important to note that, due to the low number of patients at risk in the REFLECTION All-Poly XLPE Cup group, confidence intervals are wide and the model may not be statistically strongly reliable. Additionally, this cohort demonstrates a higher proportion of re-revisions attributable to infection (38.5%) compared with the revision THA class (22.0%). Infection is a well-recognized postoperative complication that is typically influenced by patient-related and perioperative factors, rather than inherent device characteristics. Consequently, the elevated contribution of infection-related re-revisions may partly explain the observed increase in overall re-revision rates for this group.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;