MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS

Report

• Report Number: 1020279-2026-00092
• Event Type: Injury
• Date Received: January 23, 2026
• Report Date: January 23, 2026
• Manufacturer: SMITH & NEPHEW, INC.
• Product Code: JDJ
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: GM
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

REPORTING QUARTER: 4 (OCT 1 - DEC 31, 2025). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE ENDOPROTHESENREGISTER (EPRD), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN GERMANY FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY THA PROCEDURES: - CONTOUR RECONSTRUCTION RING COMPONENTS: IMPLANTED IN FORTY-SEVEN (47) HIPS BETWEEN (B)(6) 2015 AND (B)(6) 2024. FROM THESE, THREE (3) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWO (2) HIPS DUE TO INFECTION, AND ONE (1) HIP DUE TO OTHER-UNKNOWN REASONS. 2. REVISION THA PROCEDURES: - CONTOUR RECONSTRUCTION RING COMPONENTS: IMPLANTED IN ONE HUNDRED FORTY-EIGHT (148) HIPS BETWEEN (B)(6) 2014 AND (B)(6) 2024. FROM THESE, NINETEEN (19) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: EIGHT (8) HIPS DUE TO INFECTION, (3) HIPS DUE TO RECURRENT DISLOCATIONS, FOUR (4) HIPS DUE TO ASEPTIC LOOSENING, AND FOUR (4) HIPS DUE TO OTHER-UNKNOWN REASONS. - CONTOUR REINFORCEMENT RING COMPONENTS: IMPLANTED IN SEVENTY-ONE (71) HIPS BETWEEN (B)(6) 2013 AND (B)(6) 2024. FROM THESE, ELEVEN (11) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: (3) HIPS DUE TO RECURRENT DISLOCATION, ONE (1) HIP DUE TO MALPOSITION/MALALIGNMENT, THREE (3) HIPS DUE TO ASEPTIC LOOSENING, AND FOUR (4) HIPS DUE TO OTHER-UNKNOWN REASONS. ALTOGETHER, A TOTAL QUANTITY OF THREE (3) REVISIONS AND THIRTY (30) RE-REVISIONS HAVE BEEN REPORTED IN THE EPRD FOR THE CONTOUR RECONSTRUCTION RING COMPONENTS, AND CONTOUR REINFORCEMENT RING COMPONENTS RESULTING IN A TOTAL OF 33 EVENTS SUMMARIZED THROUGH THIS 3500A FORM. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATIONS, THE CONTOUR ACETABULAR SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENTS WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THIS SYSTEM IS AT LEAST AS SAFE AND EFFECTIVE AS ALL THEIR THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. EPRD REPORTS THAT FOR THE CONTOUR ACETABULAR RECONSTRUCTION RING COMPONENTS A TOTAL OF FORTY-SEVEN (47) PRIMARY THA WERE CAPTURED. THE MEAN YEARLY CUMULATIVE REVISION RATES WERE IN LINE WITH THE CLASS BASED ON THE OVERLAPPING CONFIDENCE INTERVALS ACROSS 8 YEARS OF FOLLOW-UP. HOWEVER, IT SHOULD BE NOTED THAT THE CONFIDENCE INTERVALS FOR CONTOUR RECONSTRUCTION RING COMPONENTS ARE WIDE DUE TO SMALL NUMBERS OF IMPLANTATIONS. FOR REVISION THA, A TOTAL OF ONE HUNDRED FORTY-EIGHT (148) IMPLANTATIONS WERE CAPTURED. THE MEAN YEARLY CUMULATIVE RE-REVISION RATES WERE IN LINE WITH THE CLASS BASED ON THE OVERLAPPING CONFIDENCE INTERVALS ACROSS 8 YEARS OF FOLLOW-UP. ACCORDING TO THE CONTOUR ACETABULAR REINFORCEMENT RING COMPONENTS REGISTRY REPORT, A TOTAL OF SEVENTY-ONE (71) IMPLANTATIONS WERE CAPTURED. THE MEAN YEARLY CUMULATIVE RE-REVISION RATES WERE IN LINE WITH THE CLASS BASED ON THE OVERLAPPING CONFIDENCE INTERVALS ACROSS 8 YEARS OF FOLLOW-UP. HOWEVER, IT SHOULD BE NOTED THAT THE CONFIDENCE INTERVALS FOR CONTOUR REINFORCEMENT RING COMPONENTS ARE WIDE DUE TO SMALL NUMBERS OF IMPLANTATIONS. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR 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 · 0

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-2025-00301320-1-L1,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of forty-seven (47) hips underwent primary THA procedures between 01-Jan-2015 and 31-Mar-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later revised due to infection.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of forty-seven (47) hips underwent primary THA procedures between 01-Jan-2015 and 31-Mar-2024, using CONTOUR Reconstruction Rings. From these, three (3) hips were later revised due to the following complications: two (2) hips due to infection, and one (1) hip due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Jan-2015 and 31-Mar-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of forty-seven (47) primary THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Jan-2015 and 31-Mar-2024. The mean yearly cumulative revision rates for the CONTOUR Reconstruction Rings were in line with the class based on the overlapping confidence intervals across 8 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 7.1% (0.0%¿14.6%) vs 2.6% (2.6%¿2.7%) of the class.;¿ At 2nd postoperative year: 7.1% (0.0%¿14.6%) vs 3.0% (3.0%¿3.1%) of the class.;¿ At 3rd postoperative year: 7.1% (0.0%¿14.6%) vs 3.3% (3.2%¿3.3%) of the class.;¿ At 4th postoperative year: 7.1% (0.0%¿14.6%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 5th postoperative year: 7.1% (0.0%¿14.6%) vs 3.7% (3.6%¿3.7%) of the class.;¿ At 6th postoperative year: 7.1% (0.0%¿14.6%) vs 3.9% (3.8%¿3.9%) of the class.;¿ At 7th postoperative year: 7.1% (0.0%¿14.6%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 8th postoperative year: 7.1% (0.0%¿14.6%) vs 4.3% (4.2%¿4.3%) of the class.;;It should be noted that the confidence intervals for CONTOUR Reconstruction Rings are wide due to small numbers of implantations (N=47) in comparison to the class (N= 607,338 implantations).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301320-1-L2,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of forty-seven (47) hips underwent primary THA procedures between 01-Jan-2015 and 31-Mar-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later revised due to infection.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of forty-seven (47) hips underwent primary THA procedures between 01-Jan-2015 and 31-Mar-2024, using CONTOUR Reconstruction Rings. From these, three (3) hips were later revised due to the following complications: two (2) hips due to infection, and one (1) hip due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Jan-2015 and 31-Mar-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of forty-seven (47) primary THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Jan-2015 and 31-Mar-2024. The mean yearly cumulative revision rates for the CONTOUR Reconstruction Rings were in line with the class based on the overlapping confidence intervals across 8 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 7.1% (0.0%¿14.6%) vs 2.6% (2.6%¿2.7%) of the class.;¿ At 2nd postoperative year: 7.1% (0.0%¿14.6%) vs 3.0% (3.0%¿3.1%) of the class.;¿ At 3rd postoperative year: 7.1% (0.0%¿14.6%) vs 3.3% (3.2%¿3.3%) of the class.;¿ At 4th postoperative year: 7.1% (0.0%¿14.6%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 5th postoperative year: 7.1% (0.0%¿14.6%) vs 3.7% (3.6%¿3.7%) of the class.;¿ At 6th postoperative year: 7.1% (0.0%¿14.6%) vs 3.9% (3.8%¿3.9%) of the class.;¿ At 7th postoperative year: 7.1% (0.0%¿14.6%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 8th postoperative year: 7.1% (0.0%¿14.6%) vs 4.3% (4.2%¿4.3%) of the class.;;It should be noted that the confidence intervals for CONTOUR Reconstruction Rings are wide due to small numbers of implantations (N=47) in comparison to the class (N= 607,338 implantations).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301320-1-L3,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of forty-seven (47) hips underwent primary THA procedures between 01-Jan-2015 and 31-Mar-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later revised due to other-unknown reasons.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of forty-seven (47) hips underwent primary THA procedures between 01-Jan-2015 and 31-Mar-2024, using CONTOUR Reconstruction Rings. From these, three (3) hips were later revised due to the following complications: two (2) hips due to infection, and one (1) hip due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Jan-2015 and 31-Mar-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of forty-seven (47) primary THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Jan-2015 and 31-Mar-2024. The mean yearly cumulative revision rates for the CONTOUR Reconstruction Rings were in line with the class based on the overlapping confidence intervals across 8 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 7.1% (0.0%¿14.6%) vs 2.6% (2.6%¿2.7%) of the class.;¿ At 2nd postoperative year: 7.1% (0.0%¿14.6%) vs 3.0% (3.0%¿3.1%) of the class.;¿ At 3rd postoperative year: 7.1% (0.0%¿14.6%) vs 3.3% (3.2%¿3.3%) of the class.;¿ At 4th postoperative year: 7.1% (0.0%¿14.6%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 5th postoperative year: 7.1% (0.0%¿14.6%) vs 3.7% (3.6%¿3.7%) of the class.;¿ At 6th postoperative year: 7.1% (0.0%¿14.6%) vs 3.9% (3.8%¿3.9%) of the class.;¿ At 7th postoperative year: 7.1% (0.0%¿14.6%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 8th postoperative year: 7.1% (0.0%¿14.6%) vs 4.3% (4.2%¿4.3%) of the class.;;It should be noted that the confidence intervals for CONTOUR Reconstruction Rings are wide due to small numbers of implantations (N=47) in comparison to the class (N= 607,338 implantations).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L1,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L2,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L3,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L4,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L5,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L6,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L7,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L8,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to infection.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L9,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to recurrent dislocations.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L10,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to recurrent dislocations.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L11,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to recurrent dislocations.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L12,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to aseptic loosening.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L13,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to aseptic loosening.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L14,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to aseptic loosening.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L15,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to aseptic loosening.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L16,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to other-unknown reasons.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L17,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to other-unknown reasons.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L18,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to other-unknown reasons.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301530-1-L19,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reconstruction Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using a CONTOUR Reconstruction Ring component. From these, one (1) hip was later re-revised due to other-unknown reasons.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of one hundred forty-eight (148) hips underwent revision THA procedures between 01-Aug-2014 and 29-Feb-2024, using CONTOUR Reconstruction Rings. From these, nineteen (19) hips were later re-revised due to the following complications: eight (8) hips due to infection, (3) hips due to recurrent dislocations, four (4) hips due to aseptic loosening, and three (3) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Aug-2014 and 29-Feb-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred forty-eight (148) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in Germany between 01-Aug-2014 and 29-Feb-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 11.1% (5.8%¿16.1%) vs 11.3% (11.0%¿11.5%) of the class.;¿ At 2nd postoperative year: 13.0% (7.2%¿18.5%) vs 13.2% (12.9%¿13.5%) of the class.;¿ At 3rd postoperative year: 13.0% (7.2%¿18.5%) vs 14.4% (14.1%¿14.7%) of the class.;¿ At 4th postoperative year: 14.3% (7.9%¿20.1%) vs 15.4% (15.1%¿15.7%) of the class.;¿ At 5th postoperative year: 14.3% (7.9%¿20.1%) vs 16.2% (15.9%¿16.5%) of the class.;¿ At 6th postoperative year: 14.3% (7.9%¿20.1%) vs 17.0% (16.7%¿17.4%) of the class.;¿ At 7th postoperative year: 14.3% (7.9%¿20.1%) vs 17.8% (17.4%¿18.2%) of the class.;¿ At 8th postoperative year: 14.3% (7.9%¿20.1%) vs 18.6% (18.1%¿19.0%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301314-1-L1,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reinforcement Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using a CONTOUR Reinforcement Ring component. From these, one (1) hip was later re-revised due to recurrent dislocation.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using CONTOUR Reinforcement Rings. From these, eleven (11) hips were later re-revised due to the following complications: (3) hips due to recurrent dislocation, one (1) hip due to malposition/malalignment, three (3) hips due to aseptic loosening, and four (4) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Oct-2013 and 31-Jan-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seventy-one (71) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in Germany between 01-Oct-2013 and 31-Jan-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 14.1% (5.6%¿21.8%) vs 10.9% (10.7%¿11.2%) of the class.;¿ At 2nd postoperative year: 16.2% (6.8%¿24.6%) vs 12.9% (12.6%¿13.1%) of the class.;¿ At 3rd postoperative year: 16.2% (6.8%¿24.6%) vs 14.1% (13.8%¿14.4%) of the class.;¿ At 4th postoperative year: 16.2% (6.8%¿24.6%) vs 15.1% (14.8%¿15.4%) of the class.;¿ At 5th postoperative year: 16.2% (6.8%¿24.6%) vs 15.9% (15.6%¿16.2%) of the class.;¿ At 6th postoperative year: 16.2% (6.8%¿24.6%) vs 16.7% (16.3%¿17.1%) of the class.;¿ At 7th postoperative year: 16.2% (6.8%¿24.6%) vs 17.5% (17.1%¿17.9%) of the class.;¿ At 8th postoperative year: 16.2% (6.8%¿24.6%) vs 18.3% (17.8%¿18.7%) of the class.;;It should be noted that the confidence intervals for CONTOUR Reinforcement Rings are wide due to small numbers of implantations (N=71) in comparison to the class (N= 71,105 implantations).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301314-1-L2,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reinforcement Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using a CONTOUR Reinforcement Ring component. From these, one (1) hip was later re-revised due to recurrent dislocation.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using CONTOUR Reinforcement Rings. From these, eleven (11) hips were later re-revised due to the following complications: (3) hips due to recurrent dislocation, one (1) hip due to malposition/malalignment, three (3) hips due to aseptic loosening, and four (4) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Oct-2013 and 31-Jan-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seventy-one (71) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in Germany between 01-Oct-2013 and 31-Jan-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 14.1% (5.6%¿21.8%) vs 10.9% (10.7%¿11.2%) of the class.;¿ At 2nd postoperative year: 16.2% (6.8%¿24.6%) vs 12.9% (12.6%¿13.1%) of the class.;¿ At 3rd postoperative year: 16.2% (6.8%¿24.6%) vs 14.1% (13.8%¿14.4%) of the class.;¿ At 4th postoperative year: 16.2% (6.8%¿24.6%) vs 15.1% (14.8%¿15.4%) of the class.;¿ At 5th postoperative year: 16.2% (6.8%¿24.6%) vs 15.9% (15.6%¿16.2%) of the class.;¿ At 6th postoperative year: 16.2% (6.8%¿24.6%) vs 16.7% (16.3%¿17.1%) of the class.;¿ At 7th postoperative year: 16.2% (6.8%¿24.6%) vs 17.5% (17.1%¿17.9%) of the class.;¿ At 8th postoperative year: 16.2% (6.8%¿24.6%) vs 18.3% (17.8%¿18.7%) of the class.;;It should be noted that the confidence intervals for CONTOUR Reinforcement Rings are wide due to small numbers of implantations (N=71) in comparison to the class (N= 71,105 implantations).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301314-1-L3,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reinforcement Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using a CONTOUR Reinforcement Ring component. From these, one (1) hip was later re-revised due to recurrent dislocation.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using CONTOUR Reinforcement Rings. From these, eleven (11) hips were later re-revised due to the following complications: (3) hips due to recurrent dislocation, one (1) hip due to malposition/malalignment, three (3) hips due to aseptic loosening, and four (4) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Oct-2013 and 31-Jan-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seventy-one (71) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in Germany between 01-Oct-2013 and 31-Jan-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 14.1% (5.6%¿21.8%) vs 10.9% (10.7%¿11.2%) of the class.;¿ At 2nd postoperative year: 16.2% (6.8%¿24.6%) vs 12.9% (12.6%¿13.1%) of the class.;¿ At 3rd postoperative year: 16.2% (6.8%¿24.6%) vs 14.1% (13.8%¿14.4%) of the class.;¿ At 4th postoperative year: 16.2% (6.8%¿24.6%) vs 15.1% (14.8%¿15.4%) of the class.;¿ At 5th postoperative year: 16.2% (6.8%¿24.6%) vs 15.9% (15.6%¿16.2%) of the class.;¿ At 6th postoperative year: 16.2% (6.8%¿24.6%) vs 16.7% (16.3%¿17.1%) of the class.;¿ At 7th postoperative year: 16.2% (6.8%¿24.6%) vs 17.5% (17.1%¿17.9%) of the class.;¿ At 8th postoperative year: 16.2% (6.8%¿24.6%) vs 18.3% (17.8%¿18.7%) of the class.;;It should be noted that the confidence intervals for CONTOUR Reinforcement Rings are wide due to small numbers of implantations (N=71) in comparison to the class (N= 71,105 implantations).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301314-1-L4,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reinforcement Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using a CONTOUR Reinforcement Ring component. From these, one (1) hip was later re-revised due to malposition/malalignment.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using CONTOUR Reinforcement Rings. From these, eleven (11) hips were later re-revised due to the following complications: (3) hips due to recurrent dislocation, one (1) hip due to malposition/malalignment, three (3) hips due to aseptic loosening, and four (4) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Oct-2013 and 31-Jan-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seventy-one (71) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in Germany between 01-Oct-2013 and 31-Jan-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 14.1% (5.6%¿21.8%) vs 10.9% (10.7%¿11.2%) of the class.;¿ At 2nd postoperative year: 16.2% (6.8%¿24.6%) vs 12.9% (12.6%¿13.1%) of the class.;¿ At 3rd postoperative year: 16.2% (6.8%¿24.6%) vs 14.1% (13.8%¿14.4%) of the class.;¿ At 4th postoperative year: 16.2% (6.8%¿24.6%) vs 15.1% (14.8%¿15.4%) of the class.;¿ At 5th postoperative year: 16.2% (6.8%¿24.6%) vs 15.9% (15.6%¿16.2%) of the class.;¿ At 6th postoperative year: 16.2% (6.8%¿24.6%) vs 16.7% (16.3%¿17.1%) of the class.;¿ At 7th postoperative year: 16.2% (6.8%¿24.6%) vs 17.5% (17.1%¿17.9%) of the class.;¿ At 8th postoperative year: 16.2% (6.8%¿24.6%) vs 18.3% (17.8%¿18.7%) of the class.;;It should be noted that the confidence intervals for CONTOUR Reinforcement Rings are wide due to small numbers of implantations (N=71) in comparison to the class (N= 71,105 implantations).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301314-1-L5,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reinforcement Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using a CONTOUR Reinforcement Ring component. From these, one (1) hip was later re-revised due to aseptic loosening.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using CONTOUR Reinforcement Rings. From these, eleven (11) hips were later re-revised due to the following complications: (3) hips due to recurrent dislocation, one (1) hip due to malposition/malalignment, three (3) hips due to aseptic loosening, and four (4) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Oct-2013 and 31-Jan-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seventy-one (71) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in Germany between 01-Oct-2013 and 31-Jan-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 14.1% (5.6%¿21.8%) vs 10.9% (10.7%¿11.2%) of the class.;¿ At 2nd postoperative year: 16.2% (6.8%¿24.6%) vs 12.9% (12.6%¿13.1%) of the class.;¿ At 3rd postoperative year: 16.2% (6.8%¿24.6%) vs 14.1% (13.8%¿14.4%) of the class.;¿ At 4th postoperative year: 16.2% (6.8%¿24.6%) vs 15.1% (14.8%¿15.4%) of the class.;¿ At 5th postoperative year: 16.2% (6.8%¿24.6%) vs 15.9% (15.6%¿16.2%) of the class.;¿ At 6th postoperative year: 16.2% (6.8%¿24.6%) vs 16.7% (16.3%¿17.1%) of the class.;¿ At 7th postoperative year: 16.2% (6.8%¿24.6%) vs 17.5% (17.1%¿17.9%) of the class.;¿ At 8th postoperative year: 16.2% (6.8%¿24.6%) vs 18.3% (17.8%¿18.7%) of the class.;;It should be noted that the confidence intervals for CONTOUR Reinforcement Rings are wide due to small numbers of implantations (N=71) in comparison to the class (N= 71,105 implantations).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301314-1-L6,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reinforcement Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using a CONTOUR Reinforcement Ring component. From these, one (1) hip was later re-revised due to aseptic loosening.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using CONTOUR Reinforcement Rings. From these, eleven (11) hips were later re-revised due to the following complications: (3) hips due to recurrent dislocation, one (1) hip due to malposition/malalignment, three (3) hips due to aseptic loosening, and four (4) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Oct-2013 and 31-Jan-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seventy-one (71) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in Germany between 01-Oct-2013 and 31-Jan-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 14.1% (5.6%¿21.8%) vs 10.9% (10.7%¿11.2%) of the class.;¿ At 2nd postoperative year: 16.2% (6.8%¿24.6%) vs 12.9% (12.6%¿13.1%) of the class.;¿ At 3rd postoperative year: 16.2% (6.8%¿24.6%) vs 14.1% (13.8%¿14.4%) of the class.;¿ At 4th postoperative year: 16.2% (6.8%¿24.6%) vs 15.1% (14.8%¿15.4%) of the class.;¿ At 5th postoperative year: 16.2% (6.8%¿24.6%) vs 15.9% (15.6%¿16.2%) of the class.;¿ At 6th postoperative year: 16.2% (6.8%¿24.6%) vs 16.7% (16.3%¿17.1%) of the class.;¿ At 7th postoperative year: 16.2% (6.8%¿24.6%) vs 17.5% (17.1%¿17.9%) of the class.;¿ At 8th postoperative year: 16.2% (6.8%¿24.6%) vs 18.3% (17.8%¿18.7%) of the class.;;It should be noted that the confidence intervals for CONTOUR Reinforcement Rings are wide due to small numbers of implantations (N=71) in comparison to the class (N= 71,105 implantations).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301314-1-L7,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reinforcement Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using a CONTOUR Reinforcement Ring component. From these, one (1) hip was later re-revised due to aseptic loosening.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using CONTOUR Reinforcement Rings. From these, eleven (11) hips were later re-revised due to the following complications: (3) hips due to recurrent dislocation, one (1) hip due to malposition/malalignment, three (3) hips due to aseptic loosening, and four (4) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Oct-2013 and 31-Jan-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seventy-one (71) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in Germany between 01-Oct-2013 and 31-Jan-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 14.1% (5.6%¿21.8%) vs 10.9% (10.7%¿11.2%) of the class.;¿ At 2nd postoperative year: 16.2% (6.8%¿24.6%) vs 12.9% (12.6%¿13.1%) of the class.;¿ At 3rd postoperative year: 16.2% (6.8%¿24.6%) vs 14.1% (13.8%¿14.4%) of the class.;¿ At 4th postoperative year: 16.2% (6.8%¿24.6%) vs 15.1% (14.8%¿15.4%) of the class.;¿ At 5th postoperative year: 16.2% (6.8%¿24.6%) vs 15.9% (15.6%¿16.2%) of the class.;¿ At 6th postoperative year: 16.2% (6.8%¿24.6%) vs 16.7% (16.3%¿17.1%) of the class.;¿ At 7th postoperative year: 16.2% (6.8%¿24.6%) vs 17.5% (17.1%¿17.9%) of the class.;¿ At 8th postoperative year: 16.2% (6.8%¿24.6%) vs 18.3% (17.8%¿18.7%) of the class.;;It should be noted that the confidence intervals for CONTOUR Reinforcement Rings are wide due to small numbers of implantations (N=71) in comparison to the class (N= 71,105 implantations).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301314-1-L8,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reinforcement Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using a CONTOUR Reinforcement Ring component. From these, one (1) hip was later re-revised due to other-unknown reasons.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using CONTOUR Reinforcement Rings. From these, eleven (11) hips were later re-revised due to the following complications: (3) hips due to recurrent dislocation, one (1) hip due to malposition/malalignment, three (3) hips due to aseptic loosening, and four (4) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Oct-2013 and 31-Jan-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seventy-one (71) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in Germany between 01-Oct-2013 and 31-Jan-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 14.1% (5.6%¿21.8%) vs 10.9% (10.7%¿11.2%) of the class.;¿ At 2nd postoperative year: 16.2% (6.8%¿24.6%) vs 12.9% (12.6%¿13.1%) of the class.;¿ At 3rd postoperative year: 16.2% (6.8%¿24.6%) vs 14.1% (13.8%¿14.4%) of the class.;¿ At 4th postoperative year: 16.2% (6.8%¿24.6%) vs 15.1% (14.8%¿15.4%) of the class.;¿ At 5th postoperative year: 16.2% (6.8%¿24.6%) vs 15.9% (15.6%¿16.2%) of the class.;¿ At 6th postoperative year: 16.2% (6.8%¿24.6%) vs 16.7% (16.3%¿17.1%) of the class.;¿ At 7th postoperative year: 16.2% (6.8%¿24.6%) vs 17.5% (17.1%¿17.9%) of the class.;¿ At 8th postoperative year: 16.2% (6.8%¿24.6%) vs 18.3% (17.8%¿18.7%) of the class.;;It should be noted that the confidence intervals for CONTOUR Reinforcement Rings are wide due to small numbers of implantations (N=71) in comparison to the class (N= 71,105 implantations).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301314-1-L9,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reinforcement Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using a CONTOUR Reinforcement Ring component. From these, one (1) hip was later re-revised due to other-unknown reasons.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using CONTOUR Reinforcement Rings. From these, eleven (11) hips were later re-revised due to the following complications: (3) hips due to recurrent dislocation, one (1) hip due to malposition/malalignment, three (3) hips due to aseptic loosening, and four (4) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Oct-2013 and 31-Jan-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seventy-one (71) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in Germany between 01-Oct-2013 and 31-Jan-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 14.1% (5.6%¿21.8%) vs 10.9% (10.7%¿11.2%) of the class.;¿ At 2nd postoperative year: 16.2% (6.8%¿24.6%) vs 12.9% (12.6%¿13.1%) of the class.;¿ At 3rd postoperative year: 16.2% (6.8%¿24.6%) vs 14.1% (13.8%¿14.4%) of the class.;¿ At 4th postoperative year: 16.2% (6.8%¿24.6%) vs 15.1% (14.8%¿15.4%) of the class.;¿ At 5th postoperative year: 16.2% (6.8%¿24.6%) vs 15.9% (15.6%¿16.2%) of the class.;¿ At 6th postoperative year: 16.2% (6.8%¿24.6%) vs 16.7% (16.3%¿17.1%) of the class.;¿ At 7th postoperative year: 16.2% (6.8%¿24.6%) vs 17.5% (17.1%¿17.9%) of the class.;¿ At 8th postoperative year: 16.2% (6.8%¿24.6%) vs 18.3% (17.8%¿18.7%) of the class.;;It should be noted that the confidence intervals for CONTOUR Reinforcement Rings are wide due to small numbers of implantations (N=71) in comparison to the class (N= 71,105 implantations).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301314-1-L10,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reinforcement Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using a CONTOUR Reinforcement Ring component. From these, one (1) hip was later re-revised due to other-unknown reasons.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using CONTOUR Reinforcement Rings. From these, eleven (11) hips were later re-revised due to the following complications: (3) hips due to recurrent dislocation, one (1) hip due to malposition/malalignment, three (3) hips due to aseptic loosening, and four (4) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Oct-2013 and 31-Jan-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seventy-one (71) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in Germany between 01-Oct-2013 and 31-Jan-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 14.1% (5.6%¿21.8%) vs 10.9% (10.7%¿11.2%) of the class.;¿ At 2nd postoperative year: 16.2% (6.8%¿24.6%) vs 12.9% (12.6%¿13.1%) of the class.;¿ At 3rd postoperative year: 16.2% (6.8%¿24.6%) vs 14.1% (13.8%¿14.4%) of the class.;¿ At 4th postoperative year: 16.2% (6.8%¿24.6%) vs 15.1% (14.8%¿15.4%) of the class.;¿ At 5th postoperative year: 16.2% (6.8%¿24.6%) vs 15.9% (15.6%¿16.2%) of the class.;¿ At 6th postoperative year: 16.2% (6.8%¿24.6%) vs 16.7% (16.3%¿17.1%) of the class.;¿ At 7th postoperative year: 16.2% (6.8%¿24.6%) vs 17.5% (17.1%¿17.9%) of the class.;¿ At 8th postoperative year: 16.2% (6.8%¿24.6%) vs 18.3% (17.8%¿18.7%) of the class.;;It should be noted that the confidence intervals for CONTOUR Reinforcement Rings are wide due to small numbers of implantations (N=71) in comparison to the class (N= 71,105 implantations).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00301314-1-L11,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Reinforcement Ring,,,,,,K962541,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using a CONTOUR Reinforcement Ring component. From these, one (1) hip was later re-revised due to other-unknown reasons.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seventy-one (71) hips underwent revision THA procedures between 01-Oct-2013 and 31-Jan-2024, using CONTOUR Reinforcement Rings. From these, eleven (11) hips were later re-revised due to the following complications: (3) hips due to recurrent dislocation, one (1) hip due to malposition/malalignment, three (3) hips due to aseptic loosening, and four (4) hips due to other-unknown reasons.;;Timeframe of Registry data: Implantations conducted between 01-Oct-2013 and 31-Jan-2024 in the Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of seventy-one (71) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in Germany between 01-Oct-2013 and 31-Jan-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were in line with the class based on the overlapping confidence intervals across 8 years of follow-up. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 14.1% (5.6%¿21.8%) vs 10.9% (10.7%¿11.2%) of the class.;¿ At 2nd postoperative year: 16.2% (6.8%¿24.6%) vs 12.9% (12.6%¿13.1%) of the class.;¿ At 3rd postoperative year: 16.2% (6.8%¿24.6%) vs 14.1% (13.8%¿14.4%) of the class.;¿ At 4th postoperative year: 16.2% (6.8%¿24.6%) vs 15.1% (14.8%¿15.4%) of the class.;¿ At 5th postoperative year: 16.2% (6.8%¿24.6%) vs 15.9% (15.6%¿16.2%) of the class.;¿ At 6th postoperative year: 16.2% (6.8%¿24.6%) vs 16.7% (16.3%¿17.1%) of the class.;¿ At 7th postoperative year: 16.2% (6.8%¿24.6%) vs 17.5% (17.1%¿17.9%) of the class.;¿ At 8th postoperative year: 16.2% (6.8%¿24.6%) vs 18.3% (17.8%¿18.7%) of the class.;;It should be noted that the confidence intervals for CONTOUR Reinforcement Rings are wide due to small numbers of implantations (N=71) in comparison to the class (N= 71,105 implantations).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE ENDOPROTHESENREGISTER (EPRD), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN GERMANY FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY THA PROCEDURES: - CONTOUR RECONSTRUCTION RING COMPONENTS: IMPLANTED IN FORTY-SEVEN (47) HIPS BETWEEN (B)(6) 2015 AND (B)(6) 2024. FROM THESE, THREE (3) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWO (2) HIPS DUE TO INFECTION, AND ONE (1) HIP DUE TO OTHER-UNKNOWN REASONS. 2. REVISION THA PROCEDURES: - CONTOUR RECONSTRUCTION RING COMPONENTS: IMPLANTED IN ONE HUNDRED FORTY-EIGHT (148) HIPS BETWEEN (B)(6) 2014 AND (B)(6) 2024. FROM THESE, NINETEEN (19) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: EIGHT (8) HIPS DUE TO INFECTION, (3) HIPS DUE TO RECURRENT DISLOCATIONS, FOUR (4) HIPS DUE TO ASEPTIC LOOSENING, AND FOUR (4) HIPS DUE TO OTHER-UNKNOWN REASONS. - CONTOUR REINFORCEMENT RING COMPONENTS: IMPLANTED IN SEVENTY-ONE (71) HIPS BETWEEN (B)(6) 2013 AND (B)(6) 2024. FROM THESE, ELEVEN (11) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: (3) HIPS DUE TO RECURRENT DISLOCATION, ONE (1) HIP DUE TO MALPOSITION/MALALIGNMENT, THREE (3) HIPS DUE TO ASEPTIC LOOSENING, AND FOUR (4) HIPS DUE TO OTHER-UNKNOWN REASONS. ALTOGETHER, A TOTAL QUANTITY OF THREE (3) REVISIONS AND THIRTY (30) RE-REVISIONS HAVE BEEN REPORTED IN THE EPRD FOR THE CONTOUR RECONSTRUCTION RING COMPONENTS, AND CONTOUR REINFORCEMENT RING COMPONENTS RESULTING IN A TOTAL OF 33 EVENTS SUMMARIZED THROUGH THIS 3500A FORM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
223063		MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS	JDJ	SMITH & NEPHEW, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR	Unknown

Terms

Patient problem · 5

• Aseptic loosening
• Deformity/ Disfigurement
• Insufficient Information
• Joint Dislocation
• Unspecified Infection

Product problems · 3

• Adverse Event Without Identified Device or Use Problem
• Loosening of Implant Not Related to Bone-Ingrowth
• Malposition of Device

Source type · 1

• Other

Type of report · 1

• Initial submission