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

Additional Manufacturer Narrative

REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2026). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE ENDOPROTHESENREGISTER DEUTSCHLAND (EPRD), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE GERMANY FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP ARTHROPLASTY: 1. PRIMARY TOTAL HIP ARTHROPLASTY: R3 0 DEGREE XLPE ACETABULAR LINER COMPONENT: IMPLANTED IN A TOTAL OF TWENTY-ONE THOUSAND FIVE HUNDRED AND SEVENTEEN (21,517) HIPS BETWEEN 01-MAR-2013 AND 31-MAR-2025. FROM THESE, EIGHT HUNDRED AND TWENTY-TWO (822) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: TWO HUNDRED FOUR (204) HIPS DUE TO INFECTION, ONE HUNDRED SEVEN (107) HIPS DUE TO DISLOCATION/INSTABILITY, EIGHTY SEVEN (87) HIPS DUE TO PERI-PROSTHETIC FRACTURE, EIGHTEEN (18) HIPS DUE TO MALPOSITION/MALALIGNMENT, EIGHTY FOUR (84) HIPS DUE TO ASEPTIC LOOSENING, TWENTY FOUR (24) HIPS DUE TO WEAR, AND TWO HUNDRED NINETY EIGHT (298) HIPS DUE TO OTHER/UNKNOWN REASONS. OF THE 822 TOTAL REVISION SURGERIES, 690 WERE PREVIOUSLY SUBMITTED TO FDA AND 132 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. R3 0 DEGREE+4 LATERALIZED ACETABULAR LINER COMPONENT: IMPLANTED IN A TOTAL OF A HUNDRED AND THIRTY-FIVE (135) HIPS BETWEEN 01-JAN-2016 AND 31-MAR-2025. OF THESE, THREE (3) HIPS REQUIRED REVISION DUE TO UNKNOWN REASONS. OF THE 3 TOTAL REVISION SURGERIES, 2 WERE PREVIOUSLY SUBMITTED TO FDA AND 1 NEW REVISION WAS IDENTIFIED DURING THIS REPORTING QUARTER. R3 XLPE HOODED INSERT COMPONENT: IMPLANTED IN A TOTAL OF SIX THOUSAND TWO HUNDRED NINETY (6,290) HIPS BETWEEN 01-FEB-2013 AND 31-MAR-2025. FROM THESE, TWO HUNDRED TEN (210) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: FIFTY-ONE (51) HIPS DUE TO INFECTION, TWENTY EIGHT (28) HIPS DUE TO DISLOCATION/INSTABILITY, TWENTY SIX (26) HIPS DUE TO PERIPROSTHETIC FRACTURE, FOUR (4) HIPS DUE TO MALPOSITION/MALALIGNMENT, FIFTEEN (15) HIPS DUE TO ASEPTIC LOOSENING, TWO (2) HIPS DUE TO WEAR, EIGHTY FOUR (84) HIPS DUE TO OTHER/UNKNOWN REASONS. OF THE 210 TOTAL REVISION SURGERIES, 157 WERE PREVIOUSLY SUBMITTED TO FDA AND 53 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. R3 20 DEGREE +4MM LATERALIZED ACETABULAR LINER COMPONENT: IMPLANTED IN A TOTAL OF FORTY-THREE (43) HIPS BETWEEN 01-MAY-2016 AND 28-FEB-2025. OF THESE, THREE (3) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: ONE (1) HIP DUE TO PERI-PROSTHETIC FRACTURE AND TWO (2) DUE TO OTHER/UNKNOWN REASONS. OF THE 3 TOTAL REVISION SURGERIES, 2 WERE PREVIOUSLY SUBMITTED TO FDA AND 1 NEW REVISION WAS IDENTIFIED DURING THIS REPORTING QUARTER. REFLECTION ALL-POLY XLPE CUP COMPONENT: IMPLANTED IN A TOTAL OF ONE HUNDRED AND FIFTY-EIGHT (158) HIPS BETWEEN 01-FEB-2016 AND 31-MAR-2025. OF THESE, FIVE (5) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: ONE (1) KNEE DUE TO INFECTION, TWO (2) DUE TO PERIPROSTHETIC FRACTURE, TWO (2) DUE TO OTHER/UNKNOWN REASONS. OF THE 5 TOTAL REVISION SURGERIES, 3 WERE PREVIOUSLY SUBMITTED TO FDA AND 2 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. 2. REVISION TOTAL HIP ARTHROPLASTY: R3 0 DEGREE XLPE ACETABULAR INSERT COMPONENT: IMPLANTED IN A TOTAL OF SEVEN HUNDRED AND NINETY (790) HIPS BETWEEN 01-NOV-2014 AND 31-MAR-2025. OF THESE, A HUNDRED AND THIRTY-FOUR (134) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: SIXTY EIGHT (68) HIPS DUE TO INFECTION, SIXTEEN (16) HIPS DUE TO DISLOCATION/INSTABILITY, THREE (3) HIPS DUE TO PERI PROSTHETIC FRACTURE, SIXTEEN (16) HIPS DUE TO ASEPTIC LOOSENING, SEVEN (7) HIPS DUE TO WEAR, AND TWENTY FOUR (24) HIPS DUE TO OTHER/UNKNOWN REASONS. OF THE 134 TOTAL RE-REVISION SURGERIES, 105 WERE PREVIOUSLY SUBMITTED TO FDA AND 29 NEW RE-REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. R3 XLPE HOODED INSERT COMPONENT: IMPLANTED IN A TOTAL OF FOUR HUNDRED SEVENTY-TWO (472) HIPS BETWEEN 01-JUL-2013 AND 31-MAR-2025. FROM THESE, EIGHTY ONE (81) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: FORTY FOUR (44) HIPS DUE TO INFECTION, NINE (9) HIPS DUE TO PROSTHESIS DISLOCATION/INSTABILITY, THREE (3) HIPS DUE TO PERIPROSTHETIC FRACTURE, SEVEN (7) HIPS DUE TO ASEPTIC LOOSENING, TWO (2) HIPS DUE TO WEAR, SIXTEEN (16) HIPS DUE TO OTHER/UNKNOWN REASONS. OF THE 81 TOTAL RE-REVISION SURGERIES, 68 WERE PREVIOUSLY SUBMITTED TO FDA AND 13 NEW RE-REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. REFLECTION ALL-POLY XLPE CUP COMPONENT: IMPLANTED IN A TOTAL OF FIFTY-THREE (53) HIPS BETWEEN 01-JAN-2014 AND 31-MAR-2025. OF THESE, SEVEN (7) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: ONE (1) HIP DUE TO INFECTION, ONE (1) DUE TO DISLOCATION/INSTABILITY, ONE (1) DUE TO MALPOSITION/MALALIGNMENT, TWO (2) DUE TO ASEPTIC LOOSENING, TWO (2) DUE TO OTHER/UNKNOWN REASONS. OF THE 7 TOTAL RE-REVISION SURGERIES, 6 WERE PREVIOUSLY SUBMITTED TO FDA AND 1 NEW RE-REVISION WAS IDENTIFIED DURING THIS REPORTING QUARTER. ALTOGETHER, A TOTAL QUANTITY OF 189 REVISIONS AND 43 RE-REVISIONS (232 EVENTS IN TOTAL) WERE IDENTIFIED DURING THE CURRENT REPORTING QUARTER BASED ON THE ENDOPROTHESENREGISTER DEUTSCHLAND (EPRD) FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE R3 ACETABULAR SYSTEM AND REFLECTION XLPE ALL-POLY CUP 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. FOR THE CUMULATIVE REVISION RATES OF THE R3 0 DEGREE+4 LATERALIZED ACETABULAR LINER, R3 XLPE HOODED INSERTS, R3 20 DEGREE +4MM LATERALIZED ACETABULAR LINER, AND REFLECTION ALL-POLY XLPE CUP COMPONENTS, EPRD REPORTS THAT THEY ARE PERFORMING IN LINE WITH THE RESPECTIVE CLASS SUBCATEGORY AT THE AVAILABLE FOLLOW-UP TIME BASED ON OVERLAPPING OF CONFIDENCE INTERVALS. ON THE OTHER HAND, EPRD REPORTS THAT BY OBSERVING THE CUMULATIVE REVISION RATES OF THE R3 0 DEGREE XLPE ACETABULAR LINER, THERE IS A STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN THE REVISION RATES OF THE STUDY DEVICE AND THE THR CLASS ARE PRESENT AT THE 1ST THROUGH 5TH POSTOPERATIVE YEARS, AS DETERMINED BY NON -OVERLAPPING 95% CONFIDENCE INTERVALS; AT EACH OF THESE TIME POINTS, THE STUDY DEVICE DEMONSTRATES HIGHER REVISION RATES THAN THE CLASS. ON THE OTHER HAND, AT 7, 9, AND 10 POSTOPERATIVE YEARS, THE 95% CONFIDENCE INTERVALS OVERLAP, INDICATING NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE REVISION RATES OF THE STUDY DEVICE AND THE THR CLASS AT THOSE LATER TIME POINTS. IN ANALYSIS OF THE REASONS FOR REVISION DURING THIS PERIOD, INFECTION (24.8%) [204/822] AND OTHER/UNKNOWN CAUSES (36.2%) [298/822] ACCOUNT FOR OVER A COMBINED 61% OF REASONS FOR REVISION. BOTH INFECTION AND OTHER/UNKNOWN CAUSES ARE NOT NECESSARILY RELATED TO THE R3 IMPLANT AND MAY NOT REFLECT THE PERFORMANCE OF THE DEVICE. THE CUMULATIVE RE-REVISION RATES FOR R3 0 DEGREE XLPE ACETABULAR INSERT, R3 XLPE HOODED INSERTS, AND REFLECTION ALL-POLY XLPE CUPS, SHOW THAT THERE IS NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE RE-REVISION RATES OF THE STUDY DEVICE AND THE REVISION THR CLASS AT ANY POSTOPERATIVE TIME POINT EVALUATED, AS DETERMINED BY OVERLAPPING 95% CONFIDENCE INTERVALS. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR 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

BASED ON REAL WORLD DATA FROM THE ENDOPROTHESENREGISTER DEUTSCHLAND (EPRD), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE GERMANY FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP ARTHROPLASTY: 1. PRIMARY TOTAL HIP ARTHROPLASTY R3 0 DEGREE XLPE ACETABULAR LINER COMPONENT: IMPLANTED IN A TOTAL OF TWENTY-ONE THOUSAND FIVE HUNDRED AND SEVENTEEN (21,517) HIPS BETWEEN 01-MAR-2013 AND 31-MAR-2025. FROM THESE, EIGHT HUNDRED AND TWENTY-TWO (822) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: TWO HUNDRED FOUR (204) HIPS DUE TO INFECTION, ONE HUNDRED SEVEN (107) HIPS DUE TO DISLOCATION/INSTABILITY, EIGHTY SEVEN (87) HIPS DUE TO PERI-PROSTHETIC FRACTURE, EIGHTEEN (18) HIPS DUE TO MALPOSITION/MALALIGNMENT, EIGHTY FOUR (84) HIPS DUE TO ASEPTIC LOOSENING, TWENTY FOUR (24) HIPS DUE TO WEAR, AND TWO HUNDRED NINETY EIGHT (298) HIPS DUE TO OTHER/UNKNOWN REASONS. OF THE 822 TOTAL REVISION SURGERIES, 690 WERE PREVIOUSLY SUBMITTED TO FDA AND 132 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. - R3 0 DEGREE+4 LATERALIZED ACETABULAR LINER COMPONENT: IMPLANTED IN A TOTAL OF A HUNDRED AND THIRTY-FIVE (135) HIPS BETWEEN 01-JAN-2016 AND 31-MAR-2025. OF THESE, THREE (3) HIPS REQUIRED REVISION DUE TO UNKNOWN REASONS. OF THE 3 TOTAL REVISION SURGERIES, 2 WERE PREVIOUSLY SUBMITTED TO FDA AND 1 NEW REVISION WAS IDENTIFIED DURING THIS REPORTING QUARTER. R3 XLPE HOODED INSERT COMPONENT: IMPLANTED IN A TOTAL OF SIX THOUSAND TWO HUNDRED NINETY (6,290) HIPS BETWEEN 01-FEB-2013 AND 31-MAR-2025. FROM THESE, TWO HUNDRED TEN (210) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: FIFTY-ONE (51) HIPS DUE TO INFECTION, TWENTY-EIGHT (28) HIPS DUE TO DISLOCATION/INSTABILITY, TWENTY-SIX (26) HIPS DUE TO PERIPROSTHETIC FRACTURE, FOUR (4) HIPS DUE TO MALPOSITION/MALALIGNMENT, FIFTEEN (15) HIPS DUE TO ASEPTIC LOOSENING, TWO (2) HIPS DUE TO WEAR, EIGHTY-FOUR (84) HIPS DUE TO OTHER/UNKNOWN REASONS. OF THE 210 TOTAL REVISION SURGERIES, 157 WERE PREVIOUSLY SUBMITTED TO FDA AND 53 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. R3 20 DEGREE +4MM LATERALIZED ACETABULAR LINER COMPONENT: IMPLANTED IN A TOTAL OF FORTY-THREE (43) HIPS BETWEEN 01-MAY-2016 AND 28-FEB-2025. OF THESE, THREE (3) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: ONE (1) HIP DUE TO PERI-PROSTHETIC FRACTURE AND TWO (2) DUE TO OTHER/UNKNOWN REASONS. OF THE 3 TOTAL REVISION SURGERIES, 2 WERE PREVIOUSLY SUBMITTED TO FDA AND 1 NEW REVISION WAS IDENTIFIED DURING THIS REPORTING QUARTER. REFLECTION ALL-POLY XLPE CUP COMPONENT: IMPLANTED IN A TOTAL OF ONE HUNDRED AND FIFTY-EIGHT (158) HIPS BETWEEN 01-FEB-2016 AND 31-MAR-2025. OF THESE, FIVE (5) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: ONE (1) KNEE DUE TO INFECTION, TWO (2) DUE TO PERIPROSTHETIC FRACTURE, TWO (2) DUE TO OTHER/UNKNOWN REASONS. OF THE 5 TOTAL REVISION SURGERIES, 3 WERE PREVIOUSLY SUBMITTED TO FDA AND 2 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. 2. REVISION TOTAL HIP ARTHROPLASTY: R3 0 DEGREE XLPE ACETABULAR INSERT COMPONENT: IMPLANTED IN A TOTAL OF SEVEN HUNDRED AND NINETY (790) HIPS BETWEEN 01-NOV-2014 AND 31-MAR-2025. OF THESE, A HUNDRED AND THIRTY-FOUR (134) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: SIXTY-EIGHT (68) HIPS DUE TO INFECTION, SIXTEEN (16) HIPS DUE TO DISLOCATION/INSTABILITY, THREE (3) HIPS DUE TO PERI PROSTHETIC FRACTURE, SIXTEEN (16) HIPS DUE TO ASEPTIC LOOSENING, SEVEN (7) HIPS DUE TO WEAR, AND TWENTY-FOUR (24) HIPS DUE TO OTHER/UNKNOWN REASONS. OF THE 134 TOTAL RE-REVISION SURGERIES, 105 WERE PREVIOUSLY SUBMITTED TO FDA AND 29 NEW RE-REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. R3 XLPE HOODED INSERT COMPONENT: IMPLANTED IN A TOTAL OF FOUR HUNDRED SEVENTY-TWO (472) HIPS BETWEEN 01-JUL-2013 AND 31-MAR-2025. FROM THESE, EIGHTY-ONE (81) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: FORTY-FOUR (44) HIPS DUE TO INFECTION, NINE (9) HIPS DUE TO PROSTHESIS DISLOCATION/INSTABILITY, THREE (3) HIPS DUE TO PERIPROSTHETIC FRACTURE, SEVEN (7) HIPS DUE TO ASEPTIC LOOSENING, TWO (2) HIPS DUE TO WEAR, SIXTEEN (16) HIPS DUE TO OTHER/UNKNOWN REASONS. OF THE 81 TOTAL RE-REVISION SURGERIES, 68 WERE PREVIOUSLY SUBMITTED TO FDA AND 13 NEW RE-REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. REFLECTION ALL-POLY XLPE CUP COMPONENT: IMPLANTED IN A TOTAL OF FIFTY-THREE (53) HIPS BETWEEN 01-JAN-2014 AND 31-MAR-2025. OF THESE, SEVEN (7) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: ONE (1) HIP DUE TO INFECTION, ONE (1) DUE TO DISLOCATION/INSTABILITY, ONE (1) DUE TO MALPOSITION/MALALIGNMENT, TWO (2) DUE TO ASEPTIC LOOSENING, TWO (2) DUE TO OTHER/UNKNOWN REASONS. OF THE 7 TOTAL RE-REVISION SURGERIES, 6 WERE PREVIOUSLY SUBMITTED TO FDA AND 1 NEW RE-REVISION WAS IDENTIFIED DURING THIS REPORTING QUARTER. ALTOGETHER, A TOTAL QUANTITY OF 189 REVISIONS AND 43 RE-REVISIONS (232 EVENTS IN TOTAL) WERE IDENTIFIED DURING THE CURRENT REPORTING QUARTER BASED ON THE ENDOPROTHESENREGISTER DEUTSCHLAND (EPRD) FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT.

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-2025-00266171-1-L691,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L692,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L693,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L694,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L695,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L696,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L697,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L698,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L699,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L700,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L701,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L702,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L703,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L704,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L705,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L706,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L707,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L708,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L709,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L710,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L711,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L712,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L713,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L714,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L715,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L716,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L717,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L718,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L719,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L720,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L721,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L722,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L723,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L724,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L725,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L726,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L727,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L728,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L729,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L730,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L731,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L732,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L733,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L734,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L735,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L736,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L737,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L738,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L739,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L740,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L741,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L742,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L743,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L744,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L745,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L746,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L747,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L748,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L749,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L750,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L751,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L752,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L753,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L754,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L755,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L756,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L757,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L758,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L759,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L760,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L761,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L762,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L763,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L764,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to malposition/malalignment.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L765,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to malposition/malalignment.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L766,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to malposition/malalignment.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L767,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L768,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L769,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L770,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L771,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L772,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L773,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L774,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L775,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L776,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L777,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L778,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L779,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L780,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L781,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L782,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L783,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L784,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L785,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L786,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L787,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L788,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L789,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L790,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L791,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L792,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L793,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L794,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L795,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L796,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L797,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L798,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L799,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L800,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L801,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L802,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L803,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L804,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L805,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L806,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L807,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L808,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L809,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L810,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L811,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L812,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L813,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L814,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L815,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L816,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L817,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L818,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L819,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L820,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L821,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266171-1-L822,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA procedures between 01-Mar-2013 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA between 01-Mar-2013 and 31-Mar-2025 in which an R3 0 Degree XLPE Acetabular Liner (also known as R3 XLPE Neutral) was implanted. Of these, eight hundred and twenty-two (822) hips required revision due to the following reasons: two hundred four (204) hips due to infection, one hundred seven (107) hips due to dislocation/instability, eighty seven (87) hips due to peri-prosthetic fracture, eighteen (18) hips due to malposition/malalignment, eighty four (84) hips due to aseptic loosening, twenty four (24) hips due to wear, and two hundred ninety eight (298) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Mar-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of twenty-one thousand five hundred and seventeen (21,517) hips underwent primary THA in which a R3 0 Degree XLPE Acetabular Liner was implanted between 01-Mar-2013 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (3.0%-3.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 3.6% (3.3%-3.8%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 3.8% (3.5%-4.1%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 4.0% (3.7%-4.2%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 4.1% (3.9%-4.4%) vs 3.7% (3.7%-3.8%) of the class;-At 7th postoperative year: 4.4% (4.1%-4.7%) vs 4.1% (4.1%-4.2%) of the class;-At 9th postoperative year: 4.7% (4.2%-5.1%) vs 4.6% (4.5%-4.6%) of the class;-At 10th postoperative year: 4.9% (4.3%-5.4%) vs 4.8% (4.7%-4.9%) of the class;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the revision rates of the study device and the THR class are present at the 1st through 5th postoperative years, as determined by non overlapping 95% confidence intervals; at each of these time points, the study device demonstrates higher revision rates than the class. ;On the other hand, at 7, 9, and 10 postoperative years, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those later time points. In analysis of the reasons for revision of the study device during this period, infection (24.8%) [204/822] and other/unknown causes (36.2%) [298/822] account for over a combined 61% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L106,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L107,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L108,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L109,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L110,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L111,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L112,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L113,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L114,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L115,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L116,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L117,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L118,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L119,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L120,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L121,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L122,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L123,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L124,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L125,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L126,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L127,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L128,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L129,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L130,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L131,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L132,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L133,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266172-1-L134,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Insert,,,,,,K113848,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and ninety (790) hips underwent revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 XLPE Neutral Insert. From these, one (1) hip required re-revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and ninety (790) hips underwent revision THA between 01-Nov-2014 and 31-Mar-2025 in which a R3 0 Degree XLPE Acetabular Insert (also known as R3 XLPE Neutral) was implanted. Of these, a hundred and thirty-four (134) hips required re-revision due to the following reasons: sixty eight (68) hips due to infection, sixteen (16) hips due to dislocation/instability, three (3) hips due to peri prosthetic fracture, sixteen (16) hips due to aseptic loosening, seven (7) hips due to wear, and twenty four (24) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and ninety (790) hips underwent revision THA in which a R3 0 Degree XLPE Acetabular Insert was implanted between 01-Nov-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 14.3% (11.8%-16.7%) vs 13.1% (12.9%-13.4%) of the class;-At 2nd postoperative year: 15.9% (13.2%-18.5%) vs 15.1% (14.9%-15.4%) of the class;-At 3rd postoperative year: 17.1% (14.3%-19.8%) vs 16.3% (16.1%-16.6%) of the class;-At 4th postoperative year: 17.7% (14.9%-20.5%) vs 17.4% (17.1%-17.6%) of the class;-At 5th postoperative year: 18.4% (15.4%-21.2%) vs 18.2% (17.9%-18.5%) of the class;-At 7th postoperative year: 19.3% (15.8%-22.7%) vs 19.6% (19.3%-20.0%) of the class;-At 9th postoperative year: 22.9% (16.8%-28.6%) vs 21.0% (20.6%-21.4%) of the class;-At 10th postoperative year: 22.9% (16.8%-28.6%) vs 21.7% (21.2%-22.2%) of the class;By observing the cumulative rerevision rates above, it can be determined that there is no statistically significant difference between the rerevision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266162-1-L3,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Neutral Lateralized Insert,,,,,,K113848,,IN,"It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of a hundred and thirty-five (135) hips underwent primary THA between 01-Jan-2016 and 31-Mar-2025 in which a R3 0 Degree+4 Lateralized Acetabular Liner was implanted. Of these, one (1) hip was later revised due to unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026) ;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of a hundred and thirty-five (135) hips underwent primary THA between 01-Jan-2016 and 31-Mar-2025 in which a R3 0 Degree+4 Lateralized Acetabular Liner was implanted. Of these, three (3) hips required revision due to unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2016 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of a hundred and thirty-five (135) hips underwent primary THA in which a R3 0 Degree+4 Lateralized Acetabular Liner was implanted between 01-Jan-2016 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (0.0%-5.3%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 2.5% (0.0%-5.3%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 2.5% (0.0%-5.3%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 2.5% (0.0%-5.3%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 2.5% (0.0%-5.3%) vs 3.8% (3.7%-3.8%) of the class;-At 7th postoperative year: 2.5% (0.0%-5.3%) vs 4.1% (4.1%-4.2%) 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 study device and the THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals. Although the point estimates for the study device are lower than those of the THR class across all reported years, the wide confidence intervals for the study device¿reflecting the limited number of procedures at risk¿overlap with those of the THR class, precluding the conclusion of a statistically significant difference.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L158,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L159,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L160,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L161,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L162,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L163,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L164,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L165,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L166,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L167,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L168,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L169,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L170,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L171,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L172,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L173,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L174,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L175,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L176,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L177,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L178,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L179,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L180,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L181,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L182,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L183,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to malposition/malalignment","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L184,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to malposition/malalignment","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L185,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to malposition/malalignment","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L186,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to aseptic loosening","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L187,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to aseptic loosening","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L188,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to aseptic loosening","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L189,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L190,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L191,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L192,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L193,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L194,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L195,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L196,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L197,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L198,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L199,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L200,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L201,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L202,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L203,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L204,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L205,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L206,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L207,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L208,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L209,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266177-1-L210,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, two hundred ten (210) hips were later revised due to the following reasons: fifty-one (51) hips due to infection, twenty eight (28) hips due to dislocation/instability, twenty six (26) hips due to periprosthetic fracture, four (4) hips due to malposition/malalignment, fifteen (15) hips due to aseptic loosening, two (2) hips due to wear, eighty four (84) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of six thousand two hundred ninety (6,290) hips underwent primary THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 XLPE Hooded inserts used in 4,737 hips vs 517,772 procedures listed for the class).;-At 1st postoperative year: 2.6% (2.1%¿3.1%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 2.9% (2.4%¿3.4%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.3% (2.8%¿3.8%) vs 3.4% (3.3%¿3.5%) of the class.;-At 4th postoperative year: 3.6% (3.0%¿4.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.7% (3.1%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.2% (3.5%¿5.0%) vs 4.1% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.5% (3.6%¿5.4%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.5% (3.6%¿5.4%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (R3 XLPE Hooded inserts used in 1,227 hips vs 141,236 procedures listed for the class).;-At 1st postoperative year: 2.5% (1.6%¿3.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 2.6% (1.7%¿3.5%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 2.6% (1.7%¿3.5%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 2.6% (1.7%¿3.5%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 2.6% (1.7%¿3.5%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 2.6% (1.7%¿3.5%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.3% (1.7%¿4.9%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.3% (1.7%¿4.9%) vs 4.6% (4.4%¿4.8%) of the class.;;3. THA for PF-fracture (R3 XLPE Hooded inserts used in 326 hips vs 42,724 procedures listed for the class).;-At 1st postoperative year: 4.7% (2.4%¿7.0%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.2% (3.3%¿8.9%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.2% (3.3%¿8.9%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (3.7%¿10.0%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (3.7%¿10.0%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 6.9% (3.7%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 6.9% (3.7%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The most frequent causes of revision were: Other-unknown reasons (40%) and infections (24.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266178-1-L69,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, eighty one (81) hips were later re-revised due to the following reasons: forty four (44) hips due to infection, nine (9) hips due to prosthesis dislocation/instability, three (3) hips due to periprosthetic fracture, seven (7) hips due to aseptic loosening, two (2) hips due to wear, sixteen (16) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 hundred seventy two (472) hips underwent Revision THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Aseptic Hip Revisions and Septic Hip Revisions. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Aseptic Hip Revisions (R3 XLPE Hooded inserts used in 325 hips vs 61,045 procedures listed for the class).;-At 1st postoperative year: 8.7% (5.5%¿11.8%) vs 10.2% (9.9%¿10.4%) of the class.;-At 2nd postoperative year: 9.9% (6.4%¿13.2%) vs 12.2% (11.9%¿12.4%) of the class.;-At 3rd postoperative year: 11.4% (7.6%¿15.1%) vs 13.4% (13.1%¿13.7%) of the class.;-At 4th postoperative year: 13.5% (9.0%¿17.7%) vs 14.4% (14.1%¿14.7%) of the class.;-At 5th postoperative year: 13.5% (9.0%¿17.7%) vs 15.2% (14.9%¿15.5%) of the class.;-At 7th postoperative year: 13.5% (9.0%¿17.7%) vs 16.7% (16.4%¿17.1%) of the class.;-At 9th postoperative year: 13.5% (9.0%¿17.7%) vs 18.1% (17.7%¿18.6%) of the class.;-At 10th postoperative year: 13.5% (9.0%¿17.7%) vs 18.8% (18.3%¿19.4%) of the class.;;2. Septic Hip Revisions (R3 XLPE Hooded inserts used in 147 hips vs 19,968 procedures listed for the class).;-At 1st postoperative year: 31.5% (23.4%¿38.7%) vs 27.6% (27.0%¿28.2%) of the class.;-At 2nd postoperative year: 31.5% (23.4%¿38.7%) vs 29.7% (29.0%¿30.4%) of the class.;-At 3rd postoperative year: 31.5% (23.4%¿38.7%) vs 30.9% (30.2%¿31.5%) of the class.;-At 4th postoperative year: 31.5% (23.4%¿38.7%) vs 31.9% (31.2%¿32.6%) of the class.;-At 5th postoperative year: 31.5% (23.4%¿38.7%) vs 32.6% (31.9%¿33.4%) of the class.;-At 7th postoperative year: 31.5% (23.4%¿38.7%) vs 33.9% (33.1%¿34.7%) of the class.;-At 9th postoperative year: 31.5% (23.4%¿38.7%) vs 35.2% (34.2%¿36.1%) of the class.;;The most frequent cause of revision was infections (54.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266178-1-L70,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, eighty one (81) hips were later re-revised due to the following reasons: forty four (44) hips due to infection, nine (9) hips due to prosthesis dislocation/instability, three (3) hips due to periprosthetic fracture, seven (7) hips due to aseptic loosening, two (2) hips due to wear, sixteen (16) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 hundred seventy two (472) hips underwent Revision THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Aseptic Hip Revisions and Septic Hip Revisions. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Aseptic Hip Revisions (R3 XLPE Hooded inserts used in 325 hips vs 61,045 procedures listed for the class).;-At 1st postoperative year: 8.7% (5.5%¿11.8%) vs 10.2% (9.9%¿10.4%) of the class.;-At 2nd postoperative year: 9.9% (6.4%¿13.2%) vs 12.2% (11.9%¿12.4%) of the class.;-At 3rd postoperative year: 11.4% (7.6%¿15.1%) vs 13.4% (13.1%¿13.7%) of the class.;-At 4th postoperative year: 13.5% (9.0%¿17.7%) vs 14.4% (14.1%¿14.7%) of the class.;-At 5th postoperative year: 13.5% (9.0%¿17.7%) vs 15.2% (14.9%¿15.5%) of the class.;-At 7th postoperative year: 13.5% (9.0%¿17.7%) vs 16.7% (16.4%¿17.1%) of the class.;-At 9th postoperative year: 13.5% (9.0%¿17.7%) vs 18.1% (17.7%¿18.6%) of the class.;-At 10th postoperative year: 13.5% (9.0%¿17.7%) vs 18.8% (18.3%¿19.4%) of the class.;;2. Septic Hip Revisions (R3 XLPE Hooded inserts used in 147 hips vs 19,968 procedures listed for the class).;-At 1st postoperative year: 31.5% (23.4%¿38.7%) vs 27.6% (27.0%¿28.2%) of the class.;-At 2nd postoperative year: 31.5% (23.4%¿38.7%) vs 29.7% (29.0%¿30.4%) of the class.;-At 3rd postoperative year: 31.5% (23.4%¿38.7%) vs 30.9% (30.2%¿31.5%) of the class.;-At 4th postoperative year: 31.5% (23.4%¿38.7%) vs 31.9% (31.2%¿32.6%) of the class.;-At 5th postoperative year: 31.5% (23.4%¿38.7%) vs 32.6% (31.9%¿33.4%) of the class.;-At 7th postoperative year: 31.5% (23.4%¿38.7%) vs 33.9% (33.1%¿34.7%) of the class.;-At 9th postoperative year: 31.5% (23.4%¿38.7%) vs 35.2% (34.2%¿36.1%) of the class.;;The most frequent cause of revision was infections (54.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266178-1-L71,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, eighty one (81) hips were later re-revised due to the following reasons: forty four (44) hips due to infection, nine (9) hips due to prosthesis dislocation/instability, three (3) hips due to periprosthetic fracture, seven (7) hips due to aseptic loosening, two (2) hips due to wear, sixteen (16) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 hundred seventy two (472) hips underwent Revision THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Aseptic Hip Revisions and Septic Hip Revisions. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Aseptic Hip Revisions (R3 XLPE Hooded inserts used in 325 hips vs 61,045 procedures listed for the class).;-At 1st postoperative year: 8.7% (5.5%¿11.8%) vs 10.2% (9.9%¿10.4%) of the class.;-At 2nd postoperative year: 9.9% (6.4%¿13.2%) vs 12.2% (11.9%¿12.4%) of the class.;-At 3rd postoperative year: 11.4% (7.6%¿15.1%) vs 13.4% (13.1%¿13.7%) of the class.;-At 4th postoperative year: 13.5% (9.0%¿17.7%) vs 14.4% (14.1%¿14.7%) of the class.;-At 5th postoperative year: 13.5% (9.0%¿17.7%) vs 15.2% (14.9%¿15.5%) of the class.;-At 7th postoperative year: 13.5% (9.0%¿17.7%) vs 16.7% (16.4%¿17.1%) of the class.;-At 9th postoperative year: 13.5% (9.0%¿17.7%) vs 18.1% (17.7%¿18.6%) of the class.;-At 10th postoperative year: 13.5% (9.0%¿17.7%) vs 18.8% (18.3%¿19.4%) of the class.;;2. Septic Hip Revisions (R3 XLPE Hooded inserts used in 147 hips vs 19,968 procedures listed for the class).;-At 1st postoperative year: 31.5% (23.4%¿38.7%) vs 27.6% (27.0%¿28.2%) of the class.;-At 2nd postoperative year: 31.5% (23.4%¿38.7%) vs 29.7% (29.0%¿30.4%) of the class.;-At 3rd postoperative year: 31.5% (23.4%¿38.7%) vs 30.9% (30.2%¿31.5%) of the class.;-At 4th postoperative year: 31.5% (23.4%¿38.7%) vs 31.9% (31.2%¿32.6%) of the class.;-At 5th postoperative year: 31.5% (23.4%¿38.7%) vs 32.6% (31.9%¿33.4%) of the class.;-At 7th postoperative year: 31.5% (23.4%¿38.7%) vs 33.9% (33.1%¿34.7%) of the class.;-At 9th postoperative year: 31.5% (23.4%¿38.7%) vs 35.2% (34.2%¿36.1%) of the class.;;The most frequent cause of revision was infections (54.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266178-1-L72,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, eighty one (81) hips were later re-revised due to the following reasons: forty four (44) hips due to infection, nine (9) hips due to prosthesis dislocation/instability, three (3) hips due to periprosthetic fracture, seven (7) hips due to aseptic loosening, two (2) hips due to wear, sixteen (16) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 hundred seventy two (472) hips underwent Revision THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Aseptic Hip Revisions and Septic Hip Revisions. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Aseptic Hip Revisions (R3 XLPE Hooded inserts used in 325 hips vs 61,045 procedures listed for the class).;-At 1st postoperative year: 8.7% (5.5%¿11.8%) vs 10.2% (9.9%¿10.4%) of the class.;-At 2nd postoperative year: 9.9% (6.4%¿13.2%) vs 12.2% (11.9%¿12.4%) of the class.;-At 3rd postoperative year: 11.4% (7.6%¿15.1%) vs 13.4% (13.1%¿13.7%) of the class.;-At 4th postoperative year: 13.5% (9.0%¿17.7%) vs 14.4% (14.1%¿14.7%) of the class.;-At 5th postoperative year: 13.5% (9.0%¿17.7%) vs 15.2% (14.9%¿15.5%) of the class.;-At 7th postoperative year: 13.5% (9.0%¿17.7%) vs 16.7% (16.4%¿17.1%) of the class.;-At 9th postoperative year: 13.5% (9.0%¿17.7%) vs 18.1% (17.7%¿18.6%) of the class.;-At 10th postoperative year: 13.5% (9.0%¿17.7%) vs 18.8% (18.3%¿19.4%) of the class.;;2. Septic Hip Revisions (R3 XLPE Hooded inserts used in 147 hips vs 19,968 procedures listed for the class).;-At 1st postoperative year: 31.5% (23.4%¿38.7%) vs 27.6% (27.0%¿28.2%) of the class.;-At 2nd postoperative year: 31.5% (23.4%¿38.7%) vs 29.7% (29.0%¿30.4%) of the class.;-At 3rd postoperative year: 31.5% (23.4%¿38.7%) vs 30.9% (30.2%¿31.5%) of the class.;-At 4th postoperative year: 31.5% (23.4%¿38.7%) vs 31.9% (31.2%¿32.6%) of the class.;-At 5th postoperative year: 31.5% (23.4%¿38.7%) vs 32.6% (31.9%¿33.4%) of the class.;-At 7th postoperative year: 31.5% (23.4%¿38.7%) vs 33.9% (33.1%¿34.7%) of the class.;-At 9th postoperative year: 31.5% (23.4%¿38.7%) vs 35.2% (34.2%¿36.1%) of the class.;;The most frequent cause of revision was infections (54.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266178-1-L73,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, eighty one (81) hips were later re-revised due to the following reasons: forty four (44) hips due to infection, nine (9) hips due to prosthesis dislocation/instability, three (3) hips due to periprosthetic fracture, seven (7) hips due to aseptic loosening, two (2) hips due to wear, sixteen (16) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 hundred seventy two (472) hips underwent Revision THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Aseptic Hip Revisions and Septic Hip Revisions. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Aseptic Hip Revisions (R3 XLPE Hooded inserts used in 325 hips vs 61,045 procedures listed for the class).;-At 1st postoperative year: 8.7% (5.5%¿11.8%) vs 10.2% (9.9%¿10.4%) of the class.;-At 2nd postoperative year: 9.9% (6.4%¿13.2%) vs 12.2% (11.9%¿12.4%) of the class.;-At 3rd postoperative year: 11.4% (7.6%¿15.1%) vs 13.4% (13.1%¿13.7%) of the class.;-At 4th postoperative year: 13.5% (9.0%¿17.7%) vs 14.4% (14.1%¿14.7%) of the class.;-At 5th postoperative year: 13.5% (9.0%¿17.7%) vs 15.2% (14.9%¿15.5%) of the class.;-At 7th postoperative year: 13.5% (9.0%¿17.7%) vs 16.7% (16.4%¿17.1%) of the class.;-At 9th postoperative year: 13.5% (9.0%¿17.7%) vs 18.1% (17.7%¿18.6%) of the class.;-At 10th postoperative year: 13.5% (9.0%¿17.7%) vs 18.8% (18.3%¿19.4%) of the class.;;2. Septic Hip Revisions (R3 XLPE Hooded inserts used in 147 hips vs 19,968 procedures listed for the class).;-At 1st postoperative year: 31.5% (23.4%¿38.7%) vs 27.6% (27.0%¿28.2%) of the class.;-At 2nd postoperative year: 31.5% (23.4%¿38.7%) vs 29.7% (29.0%¿30.4%) of the class.;-At 3rd postoperative year: 31.5% (23.4%¿38.7%) vs 30.9% (30.2%¿31.5%) of the class.;-At 4th postoperative year: 31.5% (23.4%¿38.7%) vs 31.9% (31.2%¿32.6%) of the class.;-At 5th postoperative year: 31.5% (23.4%¿38.7%) vs 32.6% (31.9%¿33.4%) of the class.;-At 7th postoperative year: 31.5% (23.4%¿38.7%) vs 33.9% (33.1%¿34.7%) of the class.;-At 9th postoperative year: 31.5% (23.4%¿38.7%) vs 35.2% (34.2%¿36.1%) of the class.;;The most frequent cause of revision was infections (54.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266178-1-L74,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, eighty one (81) hips were later re-revised due to the following reasons: forty four (44) hips due to infection, nine (9) hips due to prosthesis dislocation/instability, three (3) hips due to periprosthetic fracture, seven (7) hips due to aseptic loosening, two (2) hips due to wear, sixteen (16) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 hundred seventy two (472) hips underwent Revision THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Aseptic Hip Revisions and Septic Hip Revisions. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Aseptic Hip Revisions (R3 XLPE Hooded inserts used in 325 hips vs 61,045 procedures listed for the class).;-At 1st postoperative year: 8.7% (5.5%¿11.8%) vs 10.2% (9.9%¿10.4%) of the class.;-At 2nd postoperative year: 9.9% (6.4%¿13.2%) vs 12.2% (11.9%¿12.4%) of the class.;-At 3rd postoperative year: 11.4% (7.6%¿15.1%) vs 13.4% (13.1%¿13.7%) of the class.;-At 4th postoperative year: 13.5% (9.0%¿17.7%) vs 14.4% (14.1%¿14.7%) of the class.;-At 5th postoperative year: 13.5% (9.0%¿17.7%) vs 15.2% (14.9%¿15.5%) of the class.;-At 7th postoperative year: 13.5% (9.0%¿17.7%) vs 16.7% (16.4%¿17.1%) of the class.;-At 9th postoperative year: 13.5% (9.0%¿17.7%) vs 18.1% (17.7%¿18.6%) of the class.;-At 10th postoperative year: 13.5% (9.0%¿17.7%) vs 18.8% (18.3%¿19.4%) of the class.;;2. Septic Hip Revisions (R3 XLPE Hooded inserts used in 147 hips vs 19,968 procedures listed for the class).;-At 1st postoperative year: 31.5% (23.4%¿38.7%) vs 27.6% (27.0%¿28.2%) of the class.;-At 2nd postoperative year: 31.5% (23.4%¿38.7%) vs 29.7% (29.0%¿30.4%) of the class.;-At 3rd postoperative year: 31.5% (23.4%¿38.7%) vs 30.9% (30.2%¿31.5%) of the class.;-At 4th postoperative year: 31.5% (23.4%¿38.7%) vs 31.9% (31.2%¿32.6%) of the class.;-At 5th postoperative year: 31.5% (23.4%¿38.7%) vs 32.6% (31.9%¿33.4%) of the class.;-At 7th postoperative year: 31.5% (23.4%¿38.7%) vs 33.9% (33.1%¿34.7%) of the class.;-At 9th postoperative year: 31.5% (23.4%¿38.7%) vs 35.2% (34.2%¿36.1%) of the class.;;The most frequent cause of revision was infections (54.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266178-1-L75,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, eighty one (81) hips were later re-revised due to the following reasons: forty four (44) hips due to infection, nine (9) hips due to prosthesis dislocation/instability, three (3) hips due to periprosthetic fracture, seven (7) hips due to aseptic loosening, two (2) hips due to wear, sixteen (16) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 hundred seventy two (472) hips underwent Revision THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Aseptic Hip Revisions and Septic Hip Revisions. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Aseptic Hip Revisions (R3 XLPE Hooded inserts used in 325 hips vs 61,045 procedures listed for the class).;-At 1st postoperative year: 8.7% (5.5%¿11.8%) vs 10.2% (9.9%¿10.4%) of the class.;-At 2nd postoperative year: 9.9% (6.4%¿13.2%) vs 12.2% (11.9%¿12.4%) of the class.;-At 3rd postoperative year: 11.4% (7.6%¿15.1%) vs 13.4% (13.1%¿13.7%) of the class.;-At 4th postoperative year: 13.5% (9.0%¿17.7%) vs 14.4% (14.1%¿14.7%) of the class.;-At 5th postoperative year: 13.5% (9.0%¿17.7%) vs 15.2% (14.9%¿15.5%) of the class.;-At 7th postoperative year: 13.5% (9.0%¿17.7%) vs 16.7% (16.4%¿17.1%) of the class.;-At 9th postoperative year: 13.5% (9.0%¿17.7%) vs 18.1% (17.7%¿18.6%) of the class.;-At 10th postoperative year: 13.5% (9.0%¿17.7%) vs 18.8% (18.3%¿19.4%) of the class.;;2. Septic Hip Revisions (R3 XLPE Hooded inserts used in 147 hips vs 19,968 procedures listed for the class).;-At 1st postoperative year: 31.5% (23.4%¿38.7%) vs 27.6% (27.0%¿28.2%) of the class.;-At 2nd postoperative year: 31.5% (23.4%¿38.7%) vs 29.7% (29.0%¿30.4%) of the class.;-At 3rd postoperative year: 31.5% (23.4%¿38.7%) vs 30.9% (30.2%¿31.5%) of the class.;-At 4th postoperative year: 31.5% (23.4%¿38.7%) vs 31.9% (31.2%¿32.6%) of the class.;-At 5th postoperative year: 31.5% (23.4%¿38.7%) vs 32.6% (31.9%¿33.4%) of the class.;-At 7th postoperative year: 31.5% (23.4%¿38.7%) vs 33.9% (33.1%¿34.7%) of the class.;-At 9th postoperative year: 31.5% (23.4%¿38.7%) vs 35.2% (34.2%¿36.1%) of the class.;;The most frequent cause of revision was infections (54.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266178-1-L76,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, eighty one (81) hips were later re-revised due to the following reasons: forty four (44) hips due to infection, nine (9) hips due to prosthesis dislocation/instability, three (3) hips due to periprosthetic fracture, seven (7) hips due to aseptic loosening, two (2) hips due to wear, sixteen (16) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 hundred seventy two (472) hips underwent Revision THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Aseptic Hip Revisions and Septic Hip Revisions. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Aseptic Hip Revisions (R3 XLPE Hooded inserts used in 325 hips vs 61,045 procedures listed for the class).;-At 1st postoperative year: 8.7% (5.5%¿11.8%) vs 10.2% (9.9%¿10.4%) of the class.;-At 2nd postoperative year: 9.9% (6.4%¿13.2%) vs 12.2% (11.9%¿12.4%) of the class.;-At 3rd postoperative year: 11.4% (7.6%¿15.1%) vs 13.4% (13.1%¿13.7%) of the class.;-At 4th postoperative year: 13.5% (9.0%¿17.7%) vs 14.4% (14.1%¿14.7%) of the class.;-At 5th postoperative year: 13.5% (9.0%¿17.7%) vs 15.2% (14.9%¿15.5%) of the class.;-At 7th postoperative year: 13.5% (9.0%¿17.7%) vs 16.7% (16.4%¿17.1%) of the class.;-At 9th postoperative year: 13.5% (9.0%¿17.7%) vs 18.1% (17.7%¿18.6%) of the class.;-At 10th postoperative year: 13.5% (9.0%¿17.7%) vs 18.8% (18.3%¿19.4%) of the class.;;2. Septic Hip Revisions (R3 XLPE Hooded inserts used in 147 hips vs 19,968 procedures listed for the class).;-At 1st postoperative year: 31.5% (23.4%¿38.7%) vs 27.6% (27.0%¿28.2%) of the class.;-At 2nd postoperative year: 31.5% (23.4%¿38.7%) vs 29.7% (29.0%¿30.4%) of the class.;-At 3rd postoperative year: 31.5% (23.4%¿38.7%) vs 30.9% (30.2%¿31.5%) of the class.;-At 4th postoperative year: 31.5% (23.4%¿38.7%) vs 31.9% (31.2%¿32.6%) of the class.;-At 5th postoperative year: 31.5% (23.4%¿38.7%) vs 32.6% (31.9%¿33.4%) of the class.;-At 7th postoperative year: 31.5% (23.4%¿38.7%) vs 33.9% (33.1%¿34.7%) of the class.;-At 9th postoperative year: 31.5% (23.4%¿38.7%) vs 35.2% (34.2%¿36.1%) of the class.;;The most frequent cause of revision was infections (54.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266178-1-L77,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, eighty one (81) hips were later re-revised due to the following reasons: forty four (44) hips due to infection, nine (9) hips due to prosthesis dislocation/instability, three (3) hips due to periprosthetic fracture, seven (7) hips due to aseptic loosening, two (2) hips due to wear, sixteen (16) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 hundred seventy two (472) hips underwent Revision THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Aseptic Hip Revisions and Septic Hip Revisions. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Aseptic Hip Revisions (R3 XLPE Hooded inserts used in 325 hips vs 61,045 procedures listed for the class).;-At 1st postoperative year: 8.7% (5.5%¿11.8%) vs 10.2% (9.9%¿10.4%) of the class.;-At 2nd postoperative year: 9.9% (6.4%¿13.2%) vs 12.2% (11.9%¿12.4%) of the class.;-At 3rd postoperative year: 11.4% (7.6%¿15.1%) vs 13.4% (13.1%¿13.7%) of the class.;-At 4th postoperative year: 13.5% (9.0%¿17.7%) vs 14.4% (14.1%¿14.7%) of the class.;-At 5th postoperative year: 13.5% (9.0%¿17.7%) vs 15.2% (14.9%¿15.5%) of the class.;-At 7th postoperative year: 13.5% (9.0%¿17.7%) vs 16.7% (16.4%¿17.1%) of the class.;-At 9th postoperative year: 13.5% (9.0%¿17.7%) vs 18.1% (17.7%¿18.6%) of the class.;-At 10th postoperative year: 13.5% (9.0%¿17.7%) vs 18.8% (18.3%¿19.4%) of the class.;;2. Septic Hip Revisions (R3 XLPE Hooded inserts used in 147 hips vs 19,968 procedures listed for the class).;-At 1st postoperative year: 31.5% (23.4%¿38.7%) vs 27.6% (27.0%¿28.2%) of the class.;-At 2nd postoperative year: 31.5% (23.4%¿38.7%) vs 29.7% (29.0%¿30.4%) of the class.;-At 3rd postoperative year: 31.5% (23.4%¿38.7%) vs 30.9% (30.2%¿31.5%) of the class.;-At 4th postoperative year: 31.5% (23.4%¿38.7%) vs 31.9% (31.2%¿32.6%) of the class.;-At 5th postoperative year: 31.5% (23.4%¿38.7%) vs 32.6% (31.9%¿33.4%) of the class.;-At 7th postoperative year: 31.5% (23.4%¿38.7%) vs 33.9% (33.1%¿34.7%) of the class.;-At 9th postoperative year: 31.5% (23.4%¿38.7%) vs 35.2% (34.2%¿36.1%) of the class.;;The most frequent cause of revision was infections (54.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266178-1-L78,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later re-revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, eighty one (81) hips were later re-revised due to the following reasons: forty four (44) hips due to infection, nine (9) hips due to prosthesis dislocation/instability, three (3) hips due to periprosthetic fracture, seven (7) hips due to aseptic loosening, two (2) hips due to wear, sixteen (16) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 hundred seventy two (472) hips underwent Revision THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Aseptic Hip Revisions and Septic Hip Revisions. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Aseptic Hip Revisions (R3 XLPE Hooded inserts used in 325 hips vs 61,045 procedures listed for the class).;-At 1st postoperative year: 8.7% (5.5%¿11.8%) vs 10.2% (9.9%¿10.4%) of the class.;-At 2nd postoperative year: 9.9% (6.4%¿13.2%) vs 12.2% (11.9%¿12.4%) of the class.;-At 3rd postoperative year: 11.4% (7.6%¿15.1%) vs 13.4% (13.1%¿13.7%) of the class.;-At 4th postoperative year: 13.5% (9.0%¿17.7%) vs 14.4% (14.1%¿14.7%) of the class.;-At 5th postoperative year: 13.5% (9.0%¿17.7%) vs 15.2% (14.9%¿15.5%) of the class.;-At 7th postoperative year: 13.5% (9.0%¿17.7%) vs 16.7% (16.4%¿17.1%) of the class.;-At 9th postoperative year: 13.5% (9.0%¿17.7%) vs 18.1% (17.7%¿18.6%) of the class.;-At 10th postoperative year: 13.5% (9.0%¿17.7%) vs 18.8% (18.3%¿19.4%) of the class.;;2. Septic Hip Revisions (R3 XLPE Hooded inserts used in 147 hips vs 19,968 procedures listed for the class).;-At 1st postoperative year: 31.5% (23.4%¿38.7%) vs 27.6% (27.0%¿28.2%) of the class.;-At 2nd postoperative year: 31.5% (23.4%¿38.7%) vs 29.7% (29.0%¿30.4%) of the class.;-At 3rd postoperative year: 31.5% (23.4%¿38.7%) vs 30.9% (30.2%¿31.5%) of the class.;-At 4th postoperative year: 31.5% (23.4%¿38.7%) vs 31.9% (31.2%¿32.6%) of the class.;-At 5th postoperative year: 31.5% (23.4%¿38.7%) vs 32.6% (31.9%¿33.4%) of the class.;-At 7th postoperative year: 31.5% (23.4%¿38.7%) vs 33.9% (33.1%¿34.7%) of the class.;-At 9th postoperative year: 31.5% (23.4%¿38.7%) vs 35.2% (34.2%¿36.1%) of the class.;;The most frequent cause of revision was infections (54.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266178-1-L79,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later re-revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, eighty one (81) hips were later re-revised due to the following reasons: forty four (44) hips due to infection, nine (9) hips due to prosthesis dislocation/instability, three (3) hips due to periprosthetic fracture, seven (7) hips due to aseptic loosening, two (2) hips due to wear, sixteen (16) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 hundred seventy two (472) hips underwent Revision THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Aseptic Hip Revisions and Septic Hip Revisions. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Aseptic Hip Revisions (R3 XLPE Hooded inserts used in 325 hips vs 61,045 procedures listed for the class).;-At 1st postoperative year: 8.7% (5.5%¿11.8%) vs 10.2% (9.9%¿10.4%) of the class.;-At 2nd postoperative year: 9.9% (6.4%¿13.2%) vs 12.2% (11.9%¿12.4%) of the class.;-At 3rd postoperative year: 11.4% (7.6%¿15.1%) vs 13.4% (13.1%¿13.7%) of the class.;-At 4th postoperative year: 13.5% (9.0%¿17.7%) vs 14.4% (14.1%¿14.7%) of the class.;-At 5th postoperative year: 13.5% (9.0%¿17.7%) vs 15.2% (14.9%¿15.5%) of the class.;-At 7th postoperative year: 13.5% (9.0%¿17.7%) vs 16.7% (16.4%¿17.1%) of the class.;-At 9th postoperative year: 13.5% (9.0%¿17.7%) vs 18.1% (17.7%¿18.6%) of the class.;-At 10th postoperative year: 13.5% (9.0%¿17.7%) vs 18.8% (18.3%¿19.4%) of the class.;;2. Septic Hip Revisions (R3 XLPE Hooded inserts used in 147 hips vs 19,968 procedures listed for the class).;-At 1st postoperative year: 31.5% (23.4%¿38.7%) vs 27.6% (27.0%¿28.2%) of the class.;-At 2nd postoperative year: 31.5% (23.4%¿38.7%) vs 29.7% (29.0%¿30.4%) of the class.;-At 3rd postoperative year: 31.5% (23.4%¿38.7%) vs 30.9% (30.2%¿31.5%) of the class.;-At 4th postoperative year: 31.5% (23.4%¿38.7%) vs 31.9% (31.2%¿32.6%) of the class.;-At 5th postoperative year: 31.5% (23.4%¿38.7%) vs 32.6% (31.9%¿33.4%) of the class.;-At 7th postoperative year: 31.5% (23.4%¿38.7%) vs 33.9% (33.1%¿34.7%) of the class.;-At 9th postoperative year: 31.5% (23.4%¿38.7%) vs 35.2% (34.2%¿36.1%) of the class.;;The most frequent cause of revision was infections (54.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266178-1-L80,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later re-revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, eighty one (81) hips were later re-revised due to the following reasons: forty four (44) hips due to infection, nine (9) hips due to prosthesis dislocation/instability, three (3) hips due to periprosthetic fracture, seven (7) hips due to aseptic loosening, two (2) hips due to wear, sixteen (16) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 hundred seventy two (472) hips underwent Revision THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Aseptic Hip Revisions and Septic Hip Revisions. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Aseptic Hip Revisions (R3 XLPE Hooded inserts used in 325 hips vs 61,045 procedures listed for the class).;-At 1st postoperative year: 8.7% (5.5%¿11.8%) vs 10.2% (9.9%¿10.4%) of the class.;-At 2nd postoperative year: 9.9% (6.4%¿13.2%) vs 12.2% (11.9%¿12.4%) of the class.;-At 3rd postoperative year: 11.4% (7.6%¿15.1%) vs 13.4% (13.1%¿13.7%) of the class.;-At 4th postoperative year: 13.5% (9.0%¿17.7%) vs 14.4% (14.1%¿14.7%) of the class.;-At 5th postoperative year: 13.5% (9.0%¿17.7%) vs 15.2% (14.9%¿15.5%) of the class.;-At 7th postoperative year: 13.5% (9.0%¿17.7%) vs 16.7% (16.4%¿17.1%) of the class.;-At 9th postoperative year: 13.5% (9.0%¿17.7%) vs 18.1% (17.7%¿18.6%) of the class.;-At 10th postoperative year: 13.5% (9.0%¿17.7%) vs 18.8% (18.3%¿19.4%) of the class.;;2. Septic Hip Revisions (R3 XLPE Hooded inserts used in 147 hips vs 19,968 procedures listed for the class).;-At 1st postoperative year: 31.5% (23.4%¿38.7%) vs 27.6% (27.0%¿28.2%) of the class.;-At 2nd postoperative year: 31.5% (23.4%¿38.7%) vs 29.7% (29.0%¿30.4%) of the class.;-At 3rd postoperative year: 31.5% (23.4%¿38.7%) vs 30.9% (30.2%¿31.5%) of the class.;-At 4th postoperative year: 31.5% (23.4%¿38.7%) vs 31.9% (31.2%¿32.6%) of the class.;-At 5th postoperative year: 31.5% (23.4%¿38.7%) vs 32.6% (31.9%¿33.4%) of the class.;-At 7th postoperative year: 31.5% (23.4%¿38.7%) vs 33.9% (33.1%¿34.7%) of the class.;-At 9th postoperative year: 31.5% (23.4%¿38.7%) vs 35.2% (34.2%¿36.1%) of the class.;;The most frequent cause of revision was infections (54.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266178-1-L81,,7/16/2026,4/1/2026,R3 Acetabular System,R3 XLPE Hooded Insert,,,,,,K113848,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, one (1) hip was later re-revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred seventy two (472) hips underwent Revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 XLPE Hooded inserts. From these, eighty one (81) hips were later re-revised due to the following reasons: forty four (44) hips due to infection, nine (9) hips due to prosthesis dislocation/instability, three (3) hips due to periprosthetic fracture, seven (7) hips due to aseptic loosening, two (2) hips due to wear, sixteen (16) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the 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 hundred seventy two (472) hips underwent Revision THA procedure in which a R3 XLPE Hooded insert was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Aseptic Hip Revisions and Septic Hip Revisions. The R3 XLPE Hooded inserts are performing in line or lower with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Aseptic Hip Revisions (R3 XLPE Hooded inserts used in 325 hips vs 61,045 procedures listed for the class).;-At 1st postoperative year: 8.7% (5.5%¿11.8%) vs 10.2% (9.9%¿10.4%) of the class.;-At 2nd postoperative year: 9.9% (6.4%¿13.2%) vs 12.2% (11.9%¿12.4%) of the class.;-At 3rd postoperative year: 11.4% (7.6%¿15.1%) vs 13.4% (13.1%¿13.7%) of the class.;-At 4th postoperative year: 13.5% (9.0%¿17.7%) vs 14.4% (14.1%¿14.7%) of the class.;-At 5th postoperative year: 13.5% (9.0%¿17.7%) vs 15.2% (14.9%¿15.5%) of the class.;-At 7th postoperative year: 13.5% (9.0%¿17.7%) vs 16.7% (16.4%¿17.1%) of the class.;-At 9th postoperative year: 13.5% (9.0%¿17.7%) vs 18.1% (17.7%¿18.6%) of the class.;-At 10th postoperative year: 13.5% (9.0%¿17.7%) vs 18.8% (18.3%¿19.4%) of the class.;;2. Septic Hip Revisions (R3 XLPE Hooded inserts used in 147 hips vs 19,968 procedures listed for the class).;-At 1st postoperative year: 31.5% (23.4%¿38.7%) vs 27.6% (27.0%¿28.2%) of the class.;-At 2nd postoperative year: 31.5% (23.4%¿38.7%) vs 29.7% (29.0%¿30.4%) of the class.;-At 3rd postoperative year: 31.5% (23.4%¿38.7%) vs 30.9% (30.2%¿31.5%) of the class.;-At 4th postoperative year: 31.5% (23.4%¿38.7%) vs 31.9% (31.2%¿32.6%) of the class.;-At 5th postoperative year: 31.5% (23.4%¿38.7%) vs 32.6% (31.9%¿33.4%) of the class.;-At 7th postoperative year: 31.5% (23.4%¿38.7%) vs 33.9% (33.1%¿34.7%) of the class.;-At 9th postoperative year: 31.5% (23.4%¿38.7%) vs 35.2% (34.2%¿36.1%) of the class.;;The most frequent cause of revision was infections (54.3%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266175-1-L3,,7/16/2026,4/10/2026,R3 Acetabular System,R3 XLPE Hooded Lateralized Insert,,,,,,K113848,,IN,"It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of forty-three (43) hips underwent primary THA between 01-May-2016 and 28-Feb-2025 in which a R3 20 Degree +4mm Lateralized Acetabular Liner (also known as R3 Hooded Lateralized) was implanted. Of these, one (1) hip due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of forty-three (43) hips underwent primary THA between 01-May-2016 and 28-Feb-2025 in which a R3 20 Degree +4mm Lateralized Acetabular Liner (also known as R3 Hooded Lateralized) was implanted. Of these, three (3) hips required revision due to the following reasons: one (1) hip due to peri-prosthetic fracture and two (2) due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-May-2016 and 28-Feb-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of forty-three (43) hips underwent primary THA in which a R3 20 Degree +4mm Lateralized Acetabular Liner was implanted between 01-May-2016 and 28-Feb-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 7.0% (0.0%-14.4%) vs 2.7% (2.7%-2.8%) of the class;-At 2nd postoperative year: 7.0% (0.0%-14.4%) vs 3.1% (3.1%-3.2%) of the class;-At 3rd postoperative year: 7.0% (0.0%-14.4%) vs 3.4% (3.3%-3.4%) of the class;-At 4th postoperative year: 7.0% (0.0%-14.4%) vs 3.6% (3.5%-3.6%) of the class;-At 5th postoperative year: 7.0% (0.0%-14.4%) vs 3.8% (3.7%-3.8%) of the class;-At 7th postoperative year: 7.0% (0.0%-14.4%) vs 4.1% (4.1%-4.2%) 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 study device and the THR class, as determined by overlapping 95% confidence intervals at all postoperative time points evaluated. Although the point estimates for the study device are higher than those of the THR class across the reported years, the wide confidence intervals for the study device¿reflecting the limited number of procedures at risk¿overlap with those of the THR class, precluding the conclusion of a statistically significant difference.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279842-1-L4,,7/16/2026,6/5/2026,REFLECTION XLPE All-Poly Cup,REFLECTION XLPE All-Poly Cup,,,,,,K002747,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred and fifty-eight (158) hips underwent primary THA between 01-Feb-2016 and 31-Mar-2025 in which a REFLECTION All-Poly XLPE Cup was implanted. Of these, one (1) hip was later revised due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred and fifty-eight (158) hips underwent primary THA between 01-Feb-2016 and 31-Mar-2025 in which a REFLECTION All-Poly XLPE Cup was implanted. Of these, five (5) hips required revision due to the following reasons: one (1) knee due to infection, two (2) due to periprosthetic fracture, two (2) due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2016 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION All-Poly XLPE 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 hundred and fifty-eight (158) hips underwent primary THA in which a REFLECTION All-Poly XLPE Cup was implanted between 01-Feb-2016 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.3% (0.4%-6.1%) vs 2.7% (2.6%-2.7%) of the class;-At 2nd postoperative year: 3.3% (0.4%-6.1%) vs 3.0% (3.0%-3.1%) of the class;-At 3rd postoperative year: 3.3% (0.4%-6.1%) vs 3.3% (3.2%-3.3%) of the class;-At 4th postoperative year: 3.3% (0.4%-6.1%) vs 3.5% (3.4%-3.5%) of the class;-At 5th postoperative year: 3.3% (0.4%-6.1%) vs 3.7% (3.6%-3.7%) of the class;-At 7th postoperative year: 3.3% (0.4%-6.1%) vs 4.1% (4.0%-4.2%) of the class;-At 9th postoperative year: 3.3% (0.4%-6.1%) vs 4.5% (4.4%-4.6%) 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 All-Poly XLPE Cup and the THA 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279842-1-L5,,7/16/2026,6/5/2026,REFLECTION XLPE All-Poly Cup,REFLECTION XLPE All-Poly Cup,,,,,,K002747,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred and fifty-eight (158) hips underwent primary THA between 01-Feb-2016 and 31-Mar-2025 in which a REFLECTION All-Poly XLPE Cup was implanted. Of these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred and fifty-eight (158) hips underwent primary THA between 01-Feb-2016 and 31-Mar-2025 in which a REFLECTION All-Poly XLPE Cup was implanted. Of these, five (5) hips required revision due to the following reasons: one (1) knee due to infection, two (2) due to periprosthetic fracture, two (2) due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2016 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION All-Poly XLPE 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 hundred and fifty-eight (158) hips underwent primary THA in which a REFLECTION All-Poly XLPE Cup was implanted between 01-Feb-2016 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.3% (0.4%-6.1%) vs 2.7% (2.6%-2.7%) of the class;-At 2nd postoperative year: 3.3% (0.4%-6.1%) vs 3.0% (3.0%-3.1%) of the class;-At 3rd postoperative year: 3.3% (0.4%-6.1%) vs 3.3% (3.2%-3.3%) of the class;-At 4th postoperative year: 3.3% (0.4%-6.1%) vs 3.5% (3.4%-3.5%) of the class;-At 5th postoperative year: 3.3% (0.4%-6.1%) vs 3.7% (3.6%-3.7%) of the class;-At 7th postoperative year: 3.3% (0.4%-6.1%) vs 4.1% (4.0%-4.2%) of the class;-At 9th postoperative year: 3.3% (0.4%-6.1%) vs 4.5% (4.4%-4.6%) 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 All-Poly XLPE Cup and the THA 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279848-1-L7,,7/16/2026,6/5/2026,REFLECTION XLPE All-Poly Cup,REFLECTION XLPE All-Poly Cup,,,,,,K002747,,IN,"It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of fifty-three (53) hips underwent revision THA between 01-Jan-2014 and 31-Mar-2025 in which a REFLECTION All-Poly XLPE Cup was implanted. Of these, one (1) hip was later re-revised due other-unknown reasons.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of fifty-three (53) hips underwent revision THA between 01-Jan-2014 and 31-Mar-2025 in which a REFLECTION All-Poly XLPE Cup was implanted. Of these, seven (7) hips required re-revision due to the following reasons: one (1) hip due to infection, one (1) due to dislocation/instability, one (1) due to malposition/malalignment, two (2) due to aseptic loosening, two (2) due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2014 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION All-Poly XLPE 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 fifty-three (53) hips underwent revision THA in which a REFLECTION All-Poly XLPE Cup was implanted between 01-Jan-2014 and 31-Mar-2025 in Germany. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 13.6% (3.7%-22.4%) vs 10.5% (10.3%-10.7%) of the class;-At 2nd postoperative year: 13.6% (3.7%-22.4%) vs 12.5% (12.2%-12.7%) of the class;-At 3rd postoperative year: 13.6% (3.7%-22.4%) vs 13.7% (13.4%-14.0%) of the class;-At 4th postoperative year: 13.6% (3.7%-22.4%) vs 14.7% (14.4%-15.0%) of the class;-At 5th postoperative year: 13.6% (3.7%-22.4%) vs 15.5% (15.2%-15.8%) of the class;-At 7th postoperative year: 13.6% (3.7%-22.4%) vs 17.1% (16.7%-17.4%) of the class;-At 9th postoperative year: 13.6% (3.7%-22.4%) vs 18.4% (18.0%-18.9%) of the class;-At 10th postoperative year: 13.6% (3.7%-22.4%) vs 19.1% (18.6%-19.7%) of the class;By observing the cumulative re-revision rates above, it can be determined that there is no statistically significant difference between the re-revision rates of the REFLECTION All-Poly XLPE 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;