MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS

Additional Manufacturer Narrative

H11: REPORTING QUARTER: 4 (01-OCT-2025 TO 31-DEC-2025). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AOANJRR, SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP REPLACEMENT (THR): 1.PRIMARY TOTAL HIP REPLACEMENT (THR): CONTOUR ACETABULAR REINFORCEMENT RING: A TOTAL OF EIGHTY (80) HIPS UNDERWENT PRIMARY THR 01-SEP-1999 AND 26-MAY-2021 IN WHICH A CONTOUR REINFORCEMENT ACETABULAR RING WAS IMPLANTED. OF THESE, FOUR (4) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: THREE (3) HIPS DUE TO INFECTION AND ONE (1) DUE TO FRACTURE. CONTOUR ACETABULAR RECONSTRUCTION RING: A TOTAL OF TWO HUNDRED AND SIXTY-NINE (269) HIPS UNDERWENT PRIMARY THR BETWEEN 01-SEP-1999 AND 26-MAY-2021, IN WHICH A CONTOUR ACETABULAR RECONSTRUCTION RING WAS IMPLANTED. OF THESE, TWELVE (12) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: FOUR (4) HIPS DUE TO LOOSENING, FOUR (4) DUE TO PROSTHESIS DISLOCATION, THREE (3) DUE TO INFECTION, ONE (1) DUE TO WEAR ACETABULUM. 2. REVISION TOTAL HIP REPLACEMENT (THR): CONTOUR ACETABULAR REINFORCEMENT RING: A TOTAL OF SEVENTEEN (17) HIPS UNDERWENT REVISION THR IN WHICH A CONTOUR ACETABULAR REINFORCEMENT RING WAS IMPLANTED BETWEEN 01-SEP-1999 AND 26-MAY-2021 IN AUSTRALIA. OF THESE, FOUR (4) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: ONE (1) HIP DUE TO LOOSENING, TWO (2) DUE TO PROSTHESIS DISLOCATION, ONE (1) DUE TO FRACTURE. CONTOUR ACETABULAR RECONSTRUCTION RING: A TOTAL OF EIGHTY-FOUR (84) HIPS UNDERWENT REVISION THR IN WHICH A CONTOUR ACETABULAR RECONSTRUCTION RING WAS IMPLANTED BETWEEN 01-SEP-1999 AND 26-MAY-2021 IN AUSTRALIA. OF THESE, FIFTEEN (15) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: FIVE (5) HIPS DUE TO LOOSENING, FIVE (5) DUE TO PROSTHESIS DISLOCATION, TWO (2) DUE TO IMPLANT BREAKAGE ACETABULAR, TWO (2) DUE TO INFECTION, ONE (1) DUE TO TUMOUR. ALTOGETHER, A TOTAL QUANTITY OF 16 REVISIONS AND 19 RE-REVISIONS (35 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE AOANJRR FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATIONS, THE CONTOUR ACETABULAR RINGS PRESENT A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED 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 ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. AOANJRR¿S 2021 AD-HOC REPORT FOR THE SMITH+NEPHEW PROSTHESES REFERENCED ABOVE WERE REVIEWED FOR THE CORRESPONDING THR PROCEDURES ANALYZED. POST-OPERATIVE OUTCOMES FOR EACH STUDY DEVICE WERE COMPARED AGAINST THOSE OF THE CLASS, DEFINED AS ALL PROSTHESES UTILIZED IN THE CORRESPONDING PROCEDURE TYPE AS RECORDED BY THE AOANJRR. FOR REVISION THR PROCEDURES, CUMULATIVE RE-REVISION RATES FOR BOTH THE CONTOUR ACETABULAR REINFORCEMENT RING AND THE CONTOUR ACETABULAR RECONSTRUCTION RING MET THE SURVIVORSHIP OF THE IMPLANT DURING THE FIRST 10 POST-OPERATIVE YEARS, ALIGNING WITH THE ESTABLISHED BENCHMARK, AS INDICATED BY OVERLAPPING CONFIDENCE INTERVALS. SIMILARLY, CUMULATIVE REVISION RATES FOR BOTH THE CONTOUR ACETABULAR REINFORCEMENT RING AND THE CONTOUR ACETABULAR RECONSTRUCTION RING MET THE SURVIVORSHIP OF THE IMPLANT DURING THE FIRST 10 POST-OPERATIVE YEARS, ALIGNING WITH THE ESTABLISHED BENCHMARK, AS INDICATED BY OVERLAPPING CONFIDENCE INTERVALS. SPECIFIC ANALYSIS FOR EACH SUBJECT DEVICE IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR 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 AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP REPLACEMENT (THR): 1. PRIMARY TOTAL HIP REPLACEMENT (THR): CONTOUR ACETABULAR REINFORCEMENT RING: A TOTAL OF EIGHTY (80) HIPS UNDERWENT PRIMARY THR 01-SEP-1999 AND 26-MAY-2021 IN WHICH A CONTOUR REINFORCEMENT ACETABULAR RING WAS IMPLANTED. OF THESE, FOUR (4) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: THREE (3) HIPS DUE TO INFECTION AND ONE (1) DUE TO FRACTURE. CONTOUR ACETABULAR RECONSTRUCTION RING: A TOTAL OF TWO HUNDRED AND SIXTY-NINE (269) HIPS UNDERWENT PRIMARY THR BETWEEN 01-SEP-1999 AND 26-MAY-2021, IN WHICH A CONTOUR ACETABULAR RECONSTRUCTION RING WAS IMPLANTED. OF THESE, TWELVE (12) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: FOUR (4) HIPS DUE TO LOOSENING, FOUR (4) DUE TO PROSTHESIS DISLOCATION, THREE (3) DUE TO INFECTION, ONE (1) DUE TO WEAR ACETABULUM. 2. REVISION TOTAL HIP REPLACEMENT (THR): CONTOUR ACETABULAR REINFORCEMENT RING: A TOTAL OF SEVENTEEN (17) HIPS UNDERWENT REVISION THR IN WHICH A CONTOUR ACETABULAR REINFORCEMENT RING WAS IMPLANTED BETWEEN 01-SEP-1999 AND 26-MAY-2021 IN AUSTRALIA. OF THESE, FOUR (4) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: ONE (1) HIP DUE TO LOOSENING, TWO (2) DUE TO PROSTHESIS DISLOCATION, ONE (1) DUE TO FRACTURE. CONTOUR ACETABULAR RECONSTRUCTION RING: A TOTAL OF EIGHTY-FOUR (84) HIPS UNDERWENT REVISION THR IN WHICH A CONTOUR ACETABULAR RECONSTRUCTION RING WAS IMPLANTED BETWEEN 01-SEP-1999 AND 26-MAY-2021 IN AUSTRALIA. OF THESE, FIFTEEN (15) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: FIVE (5) HIPS DUE TO LOOSENING, FIVE (5) DUE TO PROSTHESIS DISLOCATION, TWO (2) DUE TO IMPLANT BREAKAGE ACETABULAR, TWO (2) DUE TO INFECTION, ONE (1) DUE TO TUMOUR. ALTOGETHER, A TOTAL QUANTITY OF 16 REVISIONS AND 19 RE-REVISIONS (35 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE AOANJRR 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-2025-00300271-1-L1,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reinforcement Ring ,,,,,,K211176,,IN,"It was reported that, based on data from the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seventeen (17) hips underwent revision THA procedures between between 01-Sep-1999 and 26-May-2021, using a CONTOUR Acetabular Reinforcement Ring . From these, one (1) hip required re-revision surgery due to loosening.","Reporting Quarter: 4 (01-Oct2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seventeen (17) hips underwent revision THR in which a CONTOUR Acetabular Reinforcement Ring was implanted between 01-Sep-1999 and 26-May-2021 in Australia. Of these, four (4) hips required re-revision due to the following reasons: one (1) hip due to loosening, two (2) due to prosthesis dislocation, one (1) due to fracture.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seventeen (17) hips underwent revision THR in which a CONTOUR Acetabular Reinforcement Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The mean re-revision rate with 95% confidence intervals was recorded during 9 post-operative years for the CONTOUR Acetabular Reinforcement Ring, which remained constant during this period: 23.5% (9.6 %¿ 51.2%).;While this data was reported for the CONTOUR Acetabular Reinforcement Ring, such data are not available for the THR Revision class. However, However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 9 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,A0102,G07001,B20,C19,D12;D15,,0;CASE-2025-00300271-1-L2,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reinforcement Ring ,,,,,,K211176,,IN,"It was reported that, based on data from the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seventeen (17) hips underwent revision THA procedures between between 01-Sep-1999 and 26-May-2021, using a CONTOUR Acetabular Reinforcement Ring . From these, one (1) hip required re-revision surgery due to prosthesis dislocation.","Reporting Quarter: 4 (01-Oct2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seventeen (17) hips underwent revision THR in which a CONTOUR Acetabular Reinforcement Ring was implanted between 01-Sep-1999 and 26-May-2021 in Australia. Of these, four (4) hips required re-revision due to the following reasons: one (1) hip due to loosening, two (2) due to prosthesis dislocation, one (1) due to fracture.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seventeen (17) hips underwent revision THR in which a CONTOUR Acetabular Reinforcement Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The mean re-revision rate with 95% confidence intervals was recorded during 9 post-operative years for the CONTOUR Acetabular Reinforcement Ring, which remained constant during this period: 23.5% (9.6 %¿ 51.2%).;While this data was reported for the CONTOUR Acetabular Reinforcement Ring, such data are not available for the THR Revision class. However, However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 9 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00300271-1-L3,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reinforcement Ring ,,,,,,K211176,,IN,"It was reported that, based on data from the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seventeen (17) hips underwent revision THA procedures between between 01-Sep-1999 and 26-May-2021, using a CONTOUR Acetabular Reinforcement Ring . From these, one (1) hip required re-revision surgery due to prosthesis dislocation.","Reporting Quarter: 4 (01-Oct2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seventeen (17) hips underwent revision THR in which a CONTOUR Acetabular Reinforcement Ring was implanted between 01-Sep-1999 and 26-May-2021 in Australia. Of these, four (4) hips required re-revision due to the following reasons: one (1) hip due to loosening, two (2) due to prosthesis dislocation, one (1) due to fracture.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seventeen (17) hips underwent revision THR in which a CONTOUR Acetabular Reinforcement Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The mean re-revision rate with 95% confidence intervals was recorded during 9 post-operative years for the CONTOUR Acetabular Reinforcement Ring, which remained constant during this period: 23.5% (9.6 %¿ 51.2%).;While this data was reported for the CONTOUR Acetabular Reinforcement Ring, such data are not available for the THR Revision class. However, However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 9 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00300271-1-L4,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reinforcement Ring ,,,,,,K211176,,IN,"It was reported that, based on data from the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seventeen (17) hips underwent revision THA procedures between between 01-Sep-1999 and 26-May-2021, using a CONTOUR Acetabular Reinforcement Ring . From these, one (1) hip required re-revision surgery due to fracture.","Reporting Quarter: 4 (01-Oct2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of seventeen (17) hips underwent revision THR in which a CONTOUR Acetabular Reinforcement Ring was implanted between 01-Sep-1999 and 26-May-2021 in Australia. Of these, four (4) hips required re-revision due to the following reasons: one (1) hip due to loosening, two (2) due to prosthesis dislocation, one (1) due to fracture.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seventeen (17) hips underwent revision THR in which a CONTOUR Acetabular Reinforcement Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The mean re-revision rate with 95% confidence intervals was recorded during 9 post-operative years for the CONTOUR Acetabular Reinforcement Ring, which remained constant during this period: 23.5% (9.6 %¿ 51.2%).;While this data was reported for the CONTOUR Acetabular Reinforcement Ring, such data are not available for the THR Revision class. However, However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 9 post-operative years appears to align with the established benchmark, as indicated by overlapping 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.",,,,,,,E2127,F1905,A24,G07001,B20,C19,D12;D15,,0;CASE-2025-00301324-1-L1,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reconstruction Ring,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR between 01-Sep-1999 and 26-May-2021 in Australia, using CONTOUR Acetabular Reconstruction Ring. From these, one (1) hip required re-revision surgery due to loosening.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted 01-Sep-1999 and 26-May-2021 in Australia. Of these, fifteen (15) hips required re-revision due to the following reasons: five (5) hips due to loosening, five (5) due to prosthesis dislocation, two (2) due to implant breakage acetabular, two (2) due to infection, one (1) due to tumour.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.4% (3.4% - 15.8%);? At 2nd post-operative year: 10.2% (5.2% - 19.5%);? At 3rd post-operative year: 14.7% (8.4% - 25.1%);? At 4th post-operative year: 19.5% (12.0% - 30.9%);? At 5th post-operative year: 19.5% (12.0% - 30.9%);? At 6th to 11th post-operative year: 21.3% (13.3% - 33.1%);While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such data are not available for the THR Revision class. However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 11 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,A0102,G07001,B20,C19,D12;D15,,0;CASE-2025-00301324-1-L2,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reconstruction Ring,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR between 01-Sep-1999 and 26-May-2021 in Australia, using CONTOUR Acetabular Reconstruction Ring. From these, one (1) hip required re-revision surgery due to loosening.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted 01-Sep-1999 and 26-May-2021 in Australia. Of these, fifteen (15) hips required re-revision due to the following reasons: five (5) hips due to loosening, five (5) due to prosthesis dislocation, two (2) due to implant breakage acetabular, two (2) due to infection, one (1) due to tumour.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.4% (3.4% - 15.8%);? At 2nd post-operative year: 10.2% (5.2% - 19.5%);? At 3rd post-operative year: 14.7% (8.4% - 25.1%);? At 4th post-operative year: 19.5% (12.0% - 30.9%);? At 5th post-operative year: 19.5% (12.0% - 30.9%);? At 6th to 11th post-operative year: 21.3% (13.3% - 33.1%);While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such data are not available for the THR Revision class. However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 11 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,A0102,G07001,B20,C19,D12;D15,,0;CASE-2025-00301324-1-L3,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reconstruction Ring,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR between 01-Sep-1999 and 26-May-2021 in Australia, using CONTOUR Acetabular Reconstruction Ring. From these, one (1) hip required re-revision surgery due to loosening.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted 01-Sep-1999 and 26-May-2021 in Australia. Of these, fifteen (15) hips required re-revision due to the following reasons: five (5) hips due to loosening, five (5) due to prosthesis dislocation, two (2) due to implant breakage acetabular, two (2) due to infection, one (1) due to tumour.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.4% (3.4% - 15.8%);? At 2nd post-operative year: 10.2% (5.2% - 19.5%);? At 3rd post-operative year: 14.7% (8.4% - 25.1%);? At 4th post-operative year: 19.5% (12.0% - 30.9%);? At 5th post-operative year: 19.5% (12.0% - 30.9%);? At 6th to 11th post-operative year: 21.3% (13.3% - 33.1%);While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such data are not available for the THR Revision class. However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 11 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,A0102,G07001,B20,C19,D12;D15,,0;CASE-2025-00301324-1-L4,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reconstruction Ring,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR between 01-Sep-1999 and 26-May-2021 in Australia, using CONTOUR Acetabular Reconstruction Ring. From these, one (1) hip required re-revision surgery due to loosening.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted 01-Sep-1999 and 26-May-2021 in Australia. Of these, fifteen (15) hips required re-revision due to the following reasons: five (5) hips due to loosening, five (5) due to prosthesis dislocation, two (2) due to implant breakage acetabular, two (2) due to infection, one (1) due to tumour.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.4% (3.4% - 15.8%);? At 2nd post-operative year: 10.2% (5.2% - 19.5%);? At 3rd post-operative year: 14.7% (8.4% - 25.1%);? At 4th post-operative year: 19.5% (12.0% - 30.9%);? At 5th post-operative year: 19.5% (12.0% - 30.9%);? At 6th to 11th post-operative year: 21.3% (13.3% - 33.1%);While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such data are not available for the THR Revision class. However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 11 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,A0102,G07001,B20,C19,D12;D15,,0;CASE-2025-00301324-1-L5,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reconstruction Ring,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR between 01-Sep-1999 and 26-May-2021 in Australia, using CONTOUR Acetabular Reconstruction Ring. From these, one (1) hip required re-revision surgery due to loosening.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted 01-Sep-1999 and 26-May-2021 in Australia. Of these, fifteen (15) hips required re-revision due to the following reasons: five (5) hips due to loosening, five (5) due to prosthesis dislocation, two (2) due to implant breakage acetabular, two (2) due to infection, one (1) due to tumour.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.4% (3.4% - 15.8%);? At 2nd post-operative year: 10.2% (5.2% - 19.5%);? At 3rd post-operative year: 14.7% (8.4% - 25.1%);? At 4th post-operative year: 19.5% (12.0% - 30.9%);? At 5th post-operative year: 19.5% (12.0% - 30.9%);? At 6th to 11th post-operative year: 21.3% (13.3% - 33.1%);While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such data are not available for the THR Revision class. However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 11 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,A0102,G07001,B20,C19,D12;D15,,0;CASE-2025-00301324-1-L6,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reconstruction Ring,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR between 01-Sep-1999 and 26-May-2021 in Australia, using CONTOUR Acetabular Reconstruction Ring. From these, one (1) hip required re-revision surgery due to prosthesis dislocation.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted 01-Sep-1999 and 26-May-2021 in Australia. Of these, fifteen (15) hips required re-revision due to the following reasons: five (5) hips due to loosening, five (5) due to prosthesis dislocation, two (2) due to implant breakage acetabular, two (2) due to infection, one (1) due to tumour.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.4% (3.4% - 15.8%);? At 2nd post-operative year: 10.2% (5.2% - 19.5%);? At 3rd post-operative year: 14.7% (8.4% - 25.1%);? At 4th post-operative year: 19.5% (12.0% - 30.9%);? At 5th post-operative year: 19.5% (12.0% - 30.9%);? At 6th to 11th post-operative year: 21.3% (13.3% - 33.1%);While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such data are not available for the THR Revision class. However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 11 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301324-1-L7,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reconstruction Ring,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR between 01-Sep-1999 and 26-May-2021 in Australia, using CONTOUR Acetabular Reconstruction Ring. From these, one (1) hip required re-revision surgery due to prosthesis dislocation.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted 01-Sep-1999 and 26-May-2021 in Australia. Of these, fifteen (15) hips required re-revision due to the following reasons: five (5) hips due to loosening, five (5) due to prosthesis dislocation, two (2) due to implant breakage acetabular, two (2) due to infection, one (1) due to tumour.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.4% (3.4% - 15.8%);? At 2nd post-operative year: 10.2% (5.2% - 19.5%);? At 3rd post-operative year: 14.7% (8.4% - 25.1%);? At 4th post-operative year: 19.5% (12.0% - 30.9%);? At 5th post-operative year: 19.5% (12.0% - 30.9%);? At 6th to 11th post-operative year: 21.3% (13.3% - 33.1%);While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such data are not available for the THR Revision class. However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 11 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301324-1-L8,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reconstruction Ring,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR between 01-Sep-1999 and 26-May-2021 in Australia, using CONTOUR Acetabular Reconstruction Ring. From these, one (1) hip required re-revision surgery due to prosthesis dislocation.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted 01-Sep-1999 and 26-May-2021 in Australia. Of these, fifteen (15) hips required re-revision due to the following reasons: five (5) hips due to loosening, five (5) due to prosthesis dislocation, two (2) due to implant breakage acetabular, two (2) due to infection, one (1) due to tumour.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.4% (3.4% - 15.8%);? At 2nd post-operative year: 10.2% (5.2% - 19.5%);? At 3rd post-operative year: 14.7% (8.4% - 25.1%);? At 4th post-operative year: 19.5% (12.0% - 30.9%);? At 5th post-operative year: 19.5% (12.0% - 30.9%);? At 6th to 11th post-operative year: 21.3% (13.3% - 33.1%);While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such data are not available for the THR Revision class. However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 11 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301324-1-L9,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reconstruction Ring,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR between 01-Sep-1999 and 26-May-2021 in Australia, using CONTOUR Acetabular Reconstruction Ring. From these, one (1) hip required re-revision surgery due to prosthesis dislocation.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted 01-Sep-1999 and 26-May-2021 in Australia. Of these, fifteen (15) hips required re-revision due to the following reasons: five (5) hips due to loosening, five (5) due to prosthesis dislocation, two (2) due to implant breakage acetabular, two (2) due to infection, one (1) due to tumour.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.4% (3.4% - 15.8%);? At 2nd post-operative year: 10.2% (5.2% - 19.5%);? At 3rd post-operative year: 14.7% (8.4% - 25.1%);? At 4th post-operative year: 19.5% (12.0% - 30.9%);? At 5th post-operative year: 19.5% (12.0% - 30.9%);? At 6th to 11th post-operative year: 21.3% (13.3% - 33.1%);While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such data are not available for the THR Revision class. However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 11 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301324-1-L10,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reconstruction Ring,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR between 01-Sep-1999 and 26-May-2021 in Australia, using CONTOUR Acetabular Reconstruction Ring. From these, one (1) hip required re-revision surgery due to prosthesis dislocation.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted 01-Sep-1999 and 26-May-2021 in Australia. Of these, fifteen (15) hips required re-revision due to the following reasons: five (5) hips due to loosening, five (5) due to prosthesis dislocation, two (2) due to implant breakage acetabular, two (2) due to infection, one (1) due to tumour.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.4% (3.4% - 15.8%);? At 2nd post-operative year: 10.2% (5.2% - 19.5%);? At 3rd post-operative year: 14.7% (8.4% - 25.1%);? At 4th post-operative year: 19.5% (12.0% - 30.9%);? At 5th post-operative year: 19.5% (12.0% - 30.9%);? At 6th to 11th post-operative year: 21.3% (13.3% - 33.1%);While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such data are not available for the THR Revision class. However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 11 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301324-1-L11,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reconstruction Ring,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR between 01-Sep-1999 and 26-May-2021 in Australia, using CONTOUR Acetabular Reconstruction Ring. From these, one (1) hip required re-revision surgery due to implant breakage acetabular.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted 01-Sep-1999 and 26-May-2021 in Australia. Of these, fifteen (15) hips required re-revision due to the following reasons: five (5) hips due to loosening, five (5) due to prosthesis dislocation, two (2) due to implant breakage acetabular, two (2) due to infection, one (1) due to tumour.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.4% (3.4% - 15.8%);? At 2nd post-operative year: 10.2% (5.2% - 19.5%);? At 3rd post-operative year: 14.7% (8.4% - 25.1%);? At 4th post-operative year: 19.5% (12.0% - 30.9%);? At 5th post-operative year: 19.5% (12.0% - 30.9%);? At 6th to 11th post-operative year: 21.3% (13.3% - 33.1%);While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such data are not available for the THR Revision class. However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 11 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,A040101,G07001,B20,C19,D12;D15,,0;CASE-2025-00301324-1-L12,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reconstruction Ring,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR between 01-Sep-1999 and 26-May-2021 in Australia, using CONTOUR Acetabular Reconstruction Ring. From these, one (1) hip required re-revision surgery due to implant breakage acetabular.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted 01-Sep-1999 and 26-May-2021 in Australia. Of these, fifteen (15) hips required re-revision due to the following reasons: five (5) hips due to loosening, five (5) due to prosthesis dislocation, two (2) due to implant breakage acetabular, two (2) due to infection, one (1) due to tumour.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.4% (3.4% - 15.8%);? At 2nd post-operative year: 10.2% (5.2% - 19.5%);? At 3rd post-operative year: 14.7% (8.4% - 25.1%);? At 4th post-operative year: 19.5% (12.0% - 30.9%);? At 5th post-operative year: 19.5% (12.0% - 30.9%);? At 6th to 11th post-operative year: 21.3% (13.3% - 33.1%);While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such data are not available for the THR Revision class. However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 11 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,A040101,G07001,B20,C19,D12;D15,,0;CASE-2025-00301324-1-L13,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reconstruction Ring,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR between 01-Sep-1999 and 26-May-2021 in Australia, using CONTOUR Acetabular Reconstruction Ring. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted 01-Sep-1999 and 26-May-2021 in Australia. Of these, fifteen (15) hips required re-revision due to the following reasons: five (5) hips due to loosening, five (5) due to prosthesis dislocation, two (2) due to implant breakage acetabular, two (2) due to infection, one (1) due to tumour.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.4% (3.4% - 15.8%);? At 2nd post-operative year: 10.2% (5.2% - 19.5%);? At 3rd post-operative year: 14.7% (8.4% - 25.1%);? At 4th post-operative year: 19.5% (12.0% - 30.9%);? At 5th post-operative year: 19.5% (12.0% - 30.9%);? At 6th to 11th post-operative year: 21.3% (13.3% - 33.1%);While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such data are not available for the THR Revision class. However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 11 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301324-1-L14,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reconstruction Ring,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR between 01-Sep-1999 and 26-May-2021 in Australia, using CONTOUR Acetabular Reconstruction Ring. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted 01-Sep-1999 and 26-May-2021 in Australia. Of these, fifteen (15) hips required re-revision due to the following reasons: five (5) hips due to loosening, five (5) due to prosthesis dislocation, two (2) due to implant breakage acetabular, two (2) due to infection, one (1) due to tumour.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.4% (3.4% - 15.8%);? At 2nd post-operative year: 10.2% (5.2% - 19.5%);? At 3rd post-operative year: 14.7% (8.4% - 25.1%);? At 4th post-operative year: 19.5% (12.0% - 30.9%);? At 5th post-operative year: 19.5% (12.0% - 30.9%);? At 6th to 11th post-operative year: 21.3% (13.3% - 33.1%);While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such data are not available for the THR Revision class. However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 11 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301324-1-L15,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring,CONTOUR Acetabular Reconstruction Ring,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR between 01-Sep-1999 and 26-May-2021 in Australia, using CONTOUR Acetabular Reconstruction Ring. From these, one (1) hip required re-revision surgery due to tumour.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted 01-Sep-1999 and 26-May-2021 in Australia. Of these, fifteen (15) hips required re-revision due to the following reasons: five (5) hips due to loosening, five (5) due to prosthesis dislocation, two (2) due to implant breakage acetabular, two (2) due to infection, one (1) due to tumour.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty-four (84) hips underwent revision THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.4% (3.4% - 15.8%);? At 2nd post-operative year: 10.2% (5.2% - 19.5%);? At 3rd post-operative year: 14.7% (8.4% - 25.1%);? At 4th post-operative year: 19.5% (12.0% - 30.9%);? At 5th post-operative year: 19.5% (12.0% - 30.9%);? At 6th to 11th post-operative year: 21.3% (13.3% - 33.1%);While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such data are not available for the THR Revision class. However, based on the cumulative percent for all diagnoses of 2nd revisions for known total conventional hip replacement, the survivorship of the implant during the first 11 post-operative years appears to align with the established benchmark, as indicated by overlapping 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.",,,,,,,E1804,F1905,A24,G07001,B20,C19,D12;D15,,0;CASE-2025-00301400-1-L1,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Reinforcement Acetabular Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty (80) hips underwent primary THR 01-Sep-1999 and 26-May-2021, using CONTOUR Reinforcement Acetabular Ring . From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec -2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty (80) hips underwent primary THR 01-Sep-1999 and 26-May-2021 in which a CONTOUR Reinforcement Acetabular Ring was implanted. Of these, four (4) hips required revision due to the following reasons: three (3) hips due to infection and one (1) due to fracture.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty (80) hips underwent primary THR in which a CONTOUR Reinforcement Acetabular Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st and 2nd post-operative year: 1.8% (0.2% - 11.8%);? At 3rd post-operative year: 4.8% (1.2% - 18.9%);? At 4th to 9th post-operative year: 8.1% (2.6% - 23.9%);As observed on the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reinforcement Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 10 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301400-1-L2,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Reinforcement Acetabular Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty (80) hips underwent primary THR 01-Sep-1999 and 26-May-2021, using CONTOUR Reinforcement Acetabular Ring . From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec -2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty (80) hips underwent primary THR 01-Sep-1999 and 26-May-2021 in which a CONTOUR Reinforcement Acetabular Ring was implanted. Of these, four (4) hips required revision due to the following reasons: three (3) hips due to infection and one (1) due to fracture.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty (80) hips underwent primary THR in which a CONTOUR Reinforcement Acetabular Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st and 2nd post-operative year: 1.8% (0.2% - 11.8%);? At 3rd post-operative year: 4.8% (1.2% - 18.9%);? At 4th to 9th post-operative year: 8.1% (2.6% - 23.9%);As observed on the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reinforcement Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 10 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301400-1-L3,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Reinforcement Acetabular Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty (80) hips underwent primary THR 01-Sep-1999 and 26-May-2021, using CONTOUR Reinforcement Acetabular Ring . From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec -2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty (80) hips underwent primary THR 01-Sep-1999 and 26-May-2021 in which a CONTOUR Reinforcement Acetabular Ring was implanted. Of these, four (4) hips required revision due to the following reasons: three (3) hips due to infection and one (1) due to fracture.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty (80) hips underwent primary THR in which a CONTOUR Reinforcement Acetabular Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st and 2nd post-operative year: 1.8% (0.2% - 11.8%);? At 3rd post-operative year: 4.8% (1.2% - 18.9%);? At 4th to 9th post-operative year: 8.1% (2.6% - 23.9%);As observed on the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reinforcement Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 10 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301400-1-L4,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Reinforcement Acetabular Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty (80) hips underwent primary THR 01-Sep-1999 and 26-May-2021, using CONTOUR Reinforcement Acetabular Ring . From these, one (1) hip required revision surgery due to fracture.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec -2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of eighty (80) hips underwent primary THR 01-Sep-1999 and 26-May-2021 in which a CONTOUR Reinforcement Acetabular Ring was implanted. Of these, four (4) hips required revision due to the following reasons: three (3) hips due to infection and one (1) due to fracture.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Rings present a favorable benefit/risk assessment when used under the conditions and for the purposes intended 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 devices are at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighty (80) hips underwent primary THR in which a CONTOUR Reinforcement Acetabular Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st and 2nd post-operative year: 1.8% (0.2% - 11.8%);? At 3rd post-operative year: 4.8% (1.2% - 18.9%);? At 4th to 9th post-operative year: 8.1% (2.6% - 23.9%);As observed on the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reinforcement Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 10 post-operative years appears to align with the established benchmark, as indicated by overlapping 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.",,,,,,,E2127,F1905,A24,G07001,B20,C19,D12;D15,,0;CASE-2025-00301409-1-L1,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Acetabular Reconstruction Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THA procedures between 01-Sep-1999 and 26-May-2021, using CONTOUR Acetabular Reconstruction Ring . From these, one (1) hip required revision surgery due to loosening.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THR between 01-Sep-1999 and 26-May-2021, in which a CONTOUR Acetabular Reconstruction Ring was implanted. Of these, twelve (12) hips required revision due to the following reasons: four (4) hips due to loosening, four (4) due to prosthesis dislocation, three (3) due to infection, one (1) due to wear acetabulum.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and sixty-nine (269) hips underwent primary THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 1.7% (0.6% - 4.6%);? At 2nd post-operative year: 3.0% (1.3% - 6.7%);? At 3rd post-operative year: 4.6% (2.3% - 9.3%);? At 4th-6th post-operative year: 5.6% (2.8% - 10.8%);? At 7th post-operative year: 7.7% (3.7% - 15.6%);As observed in the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 7 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,A0102,G07001,B20,C19,D12;D15,,0;CASE-2025-00301409-1-L2,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Acetabular Reconstruction Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THA procedures between 01-Sep-1999 and 26-May-2021, using CONTOUR Acetabular Reconstruction Ring . From these, one (1) hip required revision surgery due to loosening.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THR between 01-Sep-1999 and 26-May-2021, in which a CONTOUR Acetabular Reconstruction Ring was implanted. Of these, twelve (12) hips required revision due to the following reasons: four (4) hips due to loosening, four (4) due to prosthesis dislocation, three (3) due to infection, one (1) due to wear acetabulum.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and sixty-nine (269) hips underwent primary THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 1.7% (0.6% - 4.6%);? At 2nd post-operative year: 3.0% (1.3% - 6.7%);? At 3rd post-operative year: 4.6% (2.3% - 9.3%);? At 4th-6th post-operative year: 5.6% (2.8% - 10.8%);? At 7th post-operative year: 7.7% (3.7% - 15.6%);As observed in the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 7 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,A0102,G07001,B20,C19,D12;D15,,0;CASE-2025-00301409-1-L3,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Acetabular Reconstruction Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THA procedures between 01-Sep-1999 and 26-May-2021, using CONTOUR Acetabular Reconstruction Ring . From these, one (1) hip required revision surgery due to loosening.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THR between 01-Sep-1999 and 26-May-2021, in which a CONTOUR Acetabular Reconstruction Ring was implanted. Of these, twelve (12) hips required revision due to the following reasons: four (4) hips due to loosening, four (4) due to prosthesis dislocation, three (3) due to infection, one (1) due to wear acetabulum.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and sixty-nine (269) hips underwent primary THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 1.7% (0.6% - 4.6%);? At 2nd post-operative year: 3.0% (1.3% - 6.7%);? At 3rd post-operative year: 4.6% (2.3% - 9.3%);? At 4th-6th post-operative year: 5.6% (2.8% - 10.8%);? At 7th post-operative year: 7.7% (3.7% - 15.6%);As observed in the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 7 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,A0102,G07001,B20,C19,D12;D15,,0;CASE-2025-00301409-1-L4,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Acetabular Reconstruction Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THA procedures between 01-Sep-1999 and 26-May-2021, using CONTOUR Acetabular Reconstruction Ring . From these, one (1) hip required revision surgery due to loosening.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THR between 01-Sep-1999 and 26-May-2021, in which a CONTOUR Acetabular Reconstruction Ring was implanted. Of these, twelve (12) hips required revision due to the following reasons: four (4) hips due to loosening, four (4) due to prosthesis dislocation, three (3) due to infection, one (1) due to wear acetabulum.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and sixty-nine (269) hips underwent primary THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 1.7% (0.6% - 4.6%);? At 2nd post-operative year: 3.0% (1.3% - 6.7%);? At 3rd post-operative year: 4.6% (2.3% - 9.3%);? At 4th-6th post-operative year: 5.6% (2.8% - 10.8%);? At 7th post-operative year: 7.7% (3.7% - 15.6%);As observed in the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 7 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,A0102,G07001,B20,C19,D12;D15,,0;CASE-2025-00301409-1-L5,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Acetabular Reconstruction Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THA procedures between 01-Sep-1999 and 26-May-2021, using CONTOUR Acetabular Reconstruction Ring . From these, one (1) hip required revision surgery due to prosthesis dislocation.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THR between 01-Sep-1999 and 26-May-2021, in which a CONTOUR Acetabular Reconstruction Ring was implanted. Of these, twelve (12) hips required revision due to the following reasons: four (4) hips due to loosening, four (4) due to prosthesis dislocation, three (3) due to infection, one (1) due to wear acetabulum.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and sixty-nine (269) hips underwent primary THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 1.7% (0.6% - 4.6%);? At 2nd post-operative year: 3.0% (1.3% - 6.7%);? At 3rd post-operative year: 4.6% (2.3% - 9.3%);? At 4th-6th post-operative year: 5.6% (2.8% - 10.8%);? At 7th post-operative year: 7.7% (3.7% - 15.6%);As observed in the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 7 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301409-1-L6,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Acetabular Reconstruction Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THA procedures between 01-Sep-1999 and 26-May-2021, using CONTOUR Acetabular Reconstruction Ring . From these, one (1) hip required revision surgery due to prosthesis dislocation.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THR between 01-Sep-1999 and 26-May-2021, in which a CONTOUR Acetabular Reconstruction Ring was implanted. Of these, twelve (12) hips required revision due to the following reasons: four (4) hips due to loosening, four (4) due to prosthesis dislocation, three (3) due to infection, one (1) due to wear acetabulum.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and sixty-nine (269) hips underwent primary THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 1.7% (0.6% - 4.6%);? At 2nd post-operative year: 3.0% (1.3% - 6.7%);? At 3rd post-operative year: 4.6% (2.3% - 9.3%);? At 4th-6th post-operative year: 5.6% (2.8% - 10.8%);? At 7th post-operative year: 7.7% (3.7% - 15.6%);As observed in the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 7 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301409-1-L7,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Acetabular Reconstruction Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THA procedures between 01-Sep-1999 and 26-May-2021, using CONTOUR Acetabular Reconstruction Ring . From these, one (1) hip required revision surgery due to prosthesis dislocation.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THR between 01-Sep-1999 and 26-May-2021, in which a CONTOUR Acetabular Reconstruction Ring was implanted. Of these, twelve (12) hips required revision due to the following reasons: four (4) hips due to loosening, four (4) due to prosthesis dislocation, three (3) due to infection, one (1) due to wear acetabulum.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and sixty-nine (269) hips underwent primary THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 1.7% (0.6% - 4.6%);? At 2nd post-operative year: 3.0% (1.3% - 6.7%);? At 3rd post-operative year: 4.6% (2.3% - 9.3%);? At 4th-6th post-operative year: 5.6% (2.8% - 10.8%);? At 7th post-operative year: 7.7% (3.7% - 15.6%);As observed in the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 7 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301409-1-L8,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Acetabular Reconstruction Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THA procedures between 01-Sep-1999 and 26-May-2021, using CONTOUR Acetabular Reconstruction Ring . From these, one (1) hip required revision surgery due to prosthesis dislocation.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THR between 01-Sep-1999 and 26-May-2021, in which a CONTOUR Acetabular Reconstruction Ring was implanted. Of these, twelve (12) hips required revision due to the following reasons: four (4) hips due to loosening, four (4) due to prosthesis dislocation, three (3) due to infection, one (1) due to wear acetabulum.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and sixty-nine (269) hips underwent primary THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 1.7% (0.6% - 4.6%);? At 2nd post-operative year: 3.0% (1.3% - 6.7%);? At 3rd post-operative year: 4.6% (2.3% - 9.3%);? At 4th-6th post-operative year: 5.6% (2.8% - 10.8%);? At 7th post-operative year: 7.7% (3.7% - 15.6%);As observed in the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 7 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301409-1-L9,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Acetabular Reconstruction Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THA procedures between 01-Sep-1999 and 26-May-2021, using CONTOUR Acetabular Reconstruction Ring . From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THR between 01-Sep-1999 and 26-May-2021, in which a CONTOUR Acetabular Reconstruction Ring was implanted. Of these, twelve (12) hips required revision due to the following reasons: four (4) hips due to loosening, four (4) due to prosthesis dislocation, three (3) due to infection, one (1) due to wear acetabulum.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and sixty-nine (269) hips underwent primary THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 1.7% (0.6% - 4.6%);? At 2nd post-operative year: 3.0% (1.3% - 6.7%);? At 3rd post-operative year: 4.6% (2.3% - 9.3%);? At 4th-6th post-operative year: 5.6% (2.8% - 10.8%);? At 7th post-operative year: 7.7% (3.7% - 15.6%);As observed in the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 7 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301409-1-L10,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Acetabular Reconstruction Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THA procedures between 01-Sep-1999 and 26-May-2021, using CONTOUR Acetabular Reconstruction Ring . From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THR between 01-Sep-1999 and 26-May-2021, in which a CONTOUR Acetabular Reconstruction Ring was implanted. Of these, twelve (12) hips required revision due to the following reasons: four (4) hips due to loosening, four (4) due to prosthesis dislocation, three (3) due to infection, one (1) due to wear acetabulum.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and sixty-nine (269) hips underwent primary THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 1.7% (0.6% - 4.6%);? At 2nd post-operative year: 3.0% (1.3% - 6.7%);? At 3rd post-operative year: 4.6% (2.3% - 9.3%);? At 4th-6th post-operative year: 5.6% (2.8% - 10.8%);? At 7th post-operative year: 7.7% (3.7% - 15.6%);As observed in the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 7 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301409-1-L11,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Acetabular Reconstruction Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THA procedures between 01-Sep-1999 and 26-May-2021, using CONTOUR Acetabular Reconstruction Ring . From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THR between 01-Sep-1999 and 26-May-2021, in which a CONTOUR Acetabular Reconstruction Ring was implanted. Of these, twelve (12) hips required revision due to the following reasons: four (4) hips due to loosening, four (4) due to prosthesis dislocation, three (3) due to infection, one (1) due to wear acetabulum.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and sixty-nine (269) hips underwent primary THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 1.7% (0.6% - 4.6%);? At 2nd post-operative year: 3.0% (1.3% - 6.7%);? At 3rd post-operative year: 4.6% (2.3% - 9.3%);? At 4th-6th post-operative year: 5.6% (2.8% - 10.8%);? At 7th post-operative year: 7.7% (3.7% - 15.6%);As observed in the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 7 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,C19,D12;D15,,0;CASE-2025-00301409-1-L12,,1/23/2026,12/4/2025,CONTOUR Acetabular Ring ,CONTOUR Acetabular Reconstruction Ring ,,,,,,K211176,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THA procedures between 01-Sep-1999 and 26-May-2021, using CONTOUR Acetabular Reconstruction Ring . From these, one (1) hip required revision surgery due to wear acetabulum.","Reporting Quarter: 4 (01-Oct-2025 to 31-Dec-2025);Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of two hundred and sixty-nine (269) hips underwent primary THR between 01-Sep-1999 and 26-May-2021, in which a CONTOUR Acetabular Reconstruction Ring was implanted. Of these, twelve (12) hips required revision due to the following reasons: four (4) hips due to loosening, four (4) due to prosthesis dislocation, three (3) due to infection, one (1) due to wear acetabulum.;Timeframe of Registry Data: Implantations conducted between 01-Sep-1999 and 26-May-2021 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two hundred and sixty-nine (269) hips underwent primary THR in which a CONTOUR Acetabular Reconstruction Ring was implanted in Australia between 01-Sep-1999 and 26-May-2021. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 1.7% (0.6% - 4.6%);? At 2nd post-operative year: 3.0% (1.3% - 6.7%);? At 3rd post-operative year: 4.6% (2.3% - 9.3%);? At 4th-6th post-operative year: 5.6% (2.8% - 10.8%);? At 7th post-operative year: 7.7% (3.7% - 15.6%);As observed in the numbers above, confidence intervals are relatively large, at least in part due to the low number of implantations throughout this period. While this data was reported for the CONTOUR Acetabular Reconstruction Ring, such specific percentages are not available for the THR class. However, based on the cumulative revision rates of all diagnoses of this THR class, the survivorship of the implant during the first 7 post-operative years appears to align with the established benchmark, as indicated by overlapping 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,A040503,G07001,B20,C19,D12;D15,,0;