CONTOUR ACETABULAR RECONSTRUCTION RING
Report
- Report Number
- 1020279-2025-01026
- Event Type
- Injury
- Date Received
- June 6, 2025
- Report Date
- January 23, 2026
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CORRECTED DATA: A2 (AGE AT THE TIME OF EVENT FROM 73 TO 72), B5 (EVENT NARRATIVE), H2 (TOTAL QUANTITY OF SUMMARIZED EVENTS IS NOW 224). H11: THE SUBMISSION CONSOLIDATES PREVIOUSLY REPORTED CASES AND NEW CASES INTO A SINGLE DATASET PER FDA¿S RWD2300584 EXEMPTION GUIDANCE. OF THE TWO HUNDRED AND TWENTY-FOUR (224) REVISIONS, EIGHTY (80) WERE INCLUDED IN PRIOR QUARTERLY SUBMISSIONS FOR THE SAME REGISTRY AND ARE RE-LISTED HERE FOR COMPLETENESS AND ALIGNMENT. NO ADDITIONAL CASE-LEVEL INFORMATION BEYOND WHAT WAS ALREADY PROVIDED IS AVAILABLE FOR THOSE EIGHTY (80) EVENTS. ONE HUNDRED FORTY-FOUR (144) NEW EVENTS WERE PROVIDED DURING THIS QUARTER, THEREFORE, A TOTAL OF TWO HUNDRED AND TWENTY-FOUR (224) REVISION PROCEDURES ARE SUMMARIZED IN THIS SUBMISSION. SPECIFIC ANALYSIS FOR EACH SUBJECT DEVICE IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE.
REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2025). SUMMARY OF ADVERSE EVENTS: IT WAS REPORTED THAT, IN THE NATIONAL JOINT REGISTRY (NJR) FROM THE UNITED KINGDOM, A TOTAL OF TWO HUNDRED SEVEN (207) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 02-MAY-2003 AND 26-FEB-2025, USING CONTOUR RECONSTRUCTION RINGS. FROM THESE, FIFTY-THREE (53) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: TWO (2) HIPS DUE TO UNEXPLAINED PAIN, ELEVEN (11) HIPS DUE TO DISLOCATION/SUBLUXATION, TWO (2) HIPS DUE TO ADVERSE SOFT TISSUE REACTION, TEN (10) HIPS DUE TO INFECTION, EIGHT (8) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, THIRTEEN (13) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, FOUR (4) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, ONE (1) HIP DUE TO MALALIGNMENT OF THE SOCKET, EIGHT (8) HIPS DUE TO WEAR OF THE ACETABULAR COMPONENT, FOUR (4) HIPS DUE TO LYSIS ASSOCIATED WITH THE STEM, FOUR (4) HIPS DUE TO LYSIS ASSOCIATED WITH THE SOCKET, TWO (2) HIPS DUE TO IMPLANT FRACTURE ¿ STEM, ONE (1) HIP DUE TO IMPLANT FRACTURE ¿ SOCKET, ONE (1) HIP DUE TO DISSOCIATION OF LINER AND TEN (10) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. TIMEFRAME OF REGISTRY DATA: IMPLANTATIONS CONDUCTED BETWEEN 02-MAY-2003 AND 26-FEB-2025 IN THE UNITED KINGDOM. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE CONTOUR ACETABULAR RING PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THIS SYSTEM IS AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. ACCORDING TO THIS REGISTRY REPORT, A TOTAL OF TWO HUNDRED SEVEN (207) REVISION THA PROCEDURES WITH THE CONTOUR RECONSTRUCTION ACETABULAR RING HAVE BEEN PERFORMED IN THE UNITED KINGDOM BETWEEN 02-MAY-2003 AND 26-FEB-2025. THE MEAN YEARLY CUMULATIVE RE-REVISION RATES FOR THE CONTOUR RECONSTRUCTION RING WERE HIGHER THAN ALL OTHER CEMENTED CUPS IN THE NJR (REFERRED AS ¿THE CLASS¿ BELOW) ACROSS ALL FOLLOW UP YEARS BASED ON THE NON-OVERLAPPING CONFIDENCE INTERVALS. THIS MAY BE EXPECTED BASED ON THE CLINICAL SCENARIOS WHICH THE CONTOUR REINFORCEMENT RING WILL BE USED, SUCH AS LARGE CAVITARY DEFECTS OF THE ACETABULUM, SEGMENTAL DEFECTS THAT INVOLVE MORE THAN 50% OF THE ACETABULUM AND PELVIC DISCONTINUITY. THUS, THE SEVERITY OF THE PATIENT CONDITION TO ENABLE DEVICE USE MAY ALSO IMPACT SURVIVORSHIP OF THE DEVICE LONG-TERM. THE FOLLOWING CUMULATIVE RE-REVISION RATES WITH 95% CONFIDENCE INTERVALS ARE PRESENTED IN THIS REPORT: O AT 1ST. POSTOPERATIVE YEAR: 17.1% (12.6%-22.3%) VS 11.5% (11.2%-11.9%) OF THE CLASS. O AT 2ND. POSTOPERATIVE YEAR: 18.9% (14.1%-24.1%) VS 12.9% (12.5%-13.2%) OF THE CLASS. O AT 3RD. POSTOPERATIVE YEAR: 21.4% (16.2%-27.0%) VS 13.8% (13.4%-14.1%) OF THE CLASS. O AT 4TH. POSTOPERATIVE YEAR: 22.7% (17.4%-28.7%) VS 14.5% (14.2%-14.9%) OF THE CLASS. O AT 5TH. POSTOPERATIVE YEAR: 25.0% (19.3%-31.1%) VS 15.4% (15.0%-15.7%) OF THE CLASS. O AT 6TH. POSTOPERATIVE YEAR: 25.0% (19.3%-31.2%) VS 16.2% (15.8%-16.5%) OF THE CLASS. O AT 7TH. POSTOPERATIVE YEAR: 25.8% (20.0%-32.2%) VS 16.8% (16.4%-17.2%) OF THE CLASS. O AT 8TH. POSTOPERATIVE YEAR: 26.8% (20.8%-33.2%) VS 17.5% (17.1%-17.9%) OF THE CLASS. O AT 9TH. POSTOPERATIVE YEAR: 27.9% (21.6%-34.5%) VS 18.2% (17.8%-18.6%) OF THE CLASS. O AT 10TH. POSTOPERATIVE YEAR: 27.9% (21.6%-35.0%) VS 18.9% (18.4%-19.3%) OF THE CLASS. O AT 11TH. POSTOPERATIVE YEAR: 29.2% (22.6%-36.5%) VS 19.6% (19.1%-20.0%) OF THE CLASS. O AT 12TH. POSTOPERATIVE YEAR: 30.8% (23.8%-38.5%) VS 20.3% (19.8%-20.8%) OF THE CLASS. O AT 13TH. POSTOPERATIVE YEAR: 30.8% (23.8%-39.5%) VS 20.9% (20.4%-21.5%) OF THE CLASS. O AT 14TH. POSTOPERATIVE YEAR: 30.8% (23.8%-40.0%) VS 21.5% (21.0%-22.1%) OF THE CLASS. O AT 15TH. POSTOPERATIVE YEAR: 30.8% (23.8%-41.1%) VS 22.1% (21.5%-22.7%) OF THE CLASS. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.
CORRECTED DATA: A2 (AGE AT THE TIME OF EVENT FROM 74 TO 73), B5 (EVENT NARRATIVE), D1 (¿CONTOUR ACETABULAR RECONSTRUCTION RING¿ REMOVED FROM BRAND NAME, AS THE 3500A FORM INCORPORATES SEVERAL PRODUCTS), H2 (TOTAL QUANTITY OF SUMMARIZED EVENTS IS NOW 80). H11: THIS REPORT IS SUBMITTED IN RESPONSE TO THE FDA¿S OBSERVATIONS REGARDING SMITH+NEPHEW¿S (S+N) SUMMARY MDR REPORTING PRACTICES UNDER RWD2300584, COMMUNICATED ON JULY 1, 2025. AS A RESULT, THE MDR WITH REFERENCE 1020279-2025-01026 INCORPORATES ALL THE REAL WORD DATA SHARING THE FOLLOWING BUNDLING CRITERIA: REGISTRATION NUMBER: (B)(4), DATA SOURCE: NATIONAL JOINT REGISTRY (NJR), REPORT TYPE: SERIOUS INJURY, PRODUCT CLASSIFICATION CODE: JDJ. ADDITIONAL COMPLAINTS HAVE BEEN ADDED SINCE THE PREVIOUS SUBMISSION ON 06-JUN-2025 : CASE-2025-00269333-1 (L1-L27). EXCEPT FOR THE CORRECTED FIELDS NOTED ABOVE UNDER ¿CORRECTED DATA¿, THE INFORMATION PROVIDED IN THE REQUIRED FIELDS OF THE PRIOR 3500A FORM SUBMITTED ON 06-JUN-2025 REMAINS UNCHANGED. REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2025) SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN REVISION JOINT REPLACEMENT PROCEDURES: 1. REVISION THA PROCEDURES: - CONTOUR RECONSTRUCTION RING COMPONENTS: IMPLANTED IN TWO HUNDRED SEVEN (207) HIPS BETWEEN 02-MAY-2003 AND 26-FEB-2025. FROM THESE, FIFTY-THREE (53) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: TWO (2) HIPS DUE TO UNEXPLAINED PAIN, ELEVEN (11) HIPS DUE TO DISLOCATION/SUBLUXATION, TWO (2) HIPS DUE TO ADVERSE SOFT TISSUE REACTION, TEN (10) HIPS DUE TO INFECTION, EIGHT (8) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, THIRTEEN (13) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, FOUR (4) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, ONE (1) HIP DUE TO MALALIGNMENT OF THE SOCKET, EIGHT (8) HIPS DUE TO WEAR OF THE ACETABULAR COMPONENT, FOUR (4) HIPS DUE TO LYSIS ASSOCIATED WITH THE STEM, FOUR (4) HIPS DUE TO LYSIS ASSOCIATED WITH THE SOCKET, TWO (2) HIPS DUE TO IMPLANT FRACTURE ¿ STEM, ONE (1) HIP DUE TO IMPLANT FRACTURE ¿ SOCKET, ONE (1) HIP DUE TO DISSOCIATION OF LINER AND TEN (10) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. - CONTOUR REINFORCEMENT RING COMPONENTS: IMPLANTED IN TWO HUNDRED THIRTY-THREE (233) HIPS BETWEEN 06-MAY-2003 AND 21-NOV-2024. FROM THESE, TWENTY-SEVEN (27) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: ONE (1) HIP DUE TO UNEXPLAINED PAIN, FIVE (5) HIPS DUE TO DISLOCATION/SUBLUXATION, ONE (1) HIP DUE TO ADVERSE SOFT TISSUE REACTION, FOUR (4) HIPS DUE TO INFECTION, SEVEN (7) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, SEVEN (7) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, THREE (3) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, ONE (1) HIP DUE TO WEAR OF THE ACETABULAR COMPONENT, ONE (1) HIP DUE TO LYSIS ASSOCIATED WITH THE STEM, ONE (1) HIP DUE TO LYSIS ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO IMPLANT FRACTURE ¿ STEM, TWO (2) HIPS DUE TO DISSOCIATION OF LINER AND FOUR (4) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF EIGHTY (80) RE-REVISIONS HAVE BEEN REPORTED IN THE NJR FOR THE CONTOUR RECONSTRUCTION RING COMPONENTS, AND CONTOUR REINFORCEMENT RING COMPONENTS REFERENCED THROUGH THIS 3500A FORM. 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 DEVICE. 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. NJR BESPOKE PROMS REPORTS COMPRISING REVISION THA IMPLANTED WITH CONTOUR RECONSTRUCTION AND REINFORCEMENT RINGS WERE ANALYZED. FOR THE CONTOUR RECONSTRUCTION RING COMPONENTS, THE MEAN YEARLY CUMULATIVE RE-REVISION RATES WERE HIGHER THAN THE CUMULATIVE RE-REVISION RATE REPORTED FOR THE NJR THA REVISION CLASS (ALL OTHER CEMENTED, CEMENTLESS & HYBRID THR) ACROSS ALL FOLLOW-UP YEARS BASED ON THE NON-OVERLAPPING CONFIDENCE INTERVALS. THIS MAY BE EXPECTED BASED ON THE CLINICAL SCENARIOS WHICH WILL BE USED, SUCH AS LARGE CAVITARY DEFECTS OF THE ACETABULUM, SEGMENTAL DEFECTS THAT INVOLVE MORE THAN 50% OF THE ACETABULUM AND PELVIC DISCONTINUITY. THUS, THE SEVERITY OF THE PATIENT CONDITION TO ENABLE DEVICE USE MAY ALSO IMPACT SURVIVORSHIP OF THE DEVICE LONG-TERM. FOR THE CONTOUR REINFORCEMENT RING COMPONENTS, THE MEAN YEARLY CUMULATIVE RE-REVISION RATES WERE SIGNIFICANTLY LOWER THAN THE THA-NJR CLASS (CEMENTED, CEMENTLESS AND HYBRID THA) ACROSS ALL FOLLOW-UP YEARS BASED ON THE NON-OVERLAPPING CONFIDENCE INTERVALS. SPECIFIC ANALYSIS IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.
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-2025-00269331-1-L1,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L2,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L3,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L4,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L5,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L6,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L7,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L8,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L9,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L10,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L11,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L12,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L13,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L14,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L15,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L16,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L17,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L18,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L19,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L20,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L21,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L22,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L23,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L24,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L25,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L26,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L27,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L28,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L29,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L30,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L31,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L32,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L33,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L34,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L35,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L36,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L37,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L38,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L39,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L40,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L41,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L42,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L43,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L44,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L45,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L46,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L47,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L48,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L49,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L50,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L51,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L52,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L53,,6/6/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred seven (207) hips underwent revision THA procedures between 02-May-2003 and 26-Feb-2025, using CONTOUR Reconstruction Rings. From these, fifty-three (53) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, eleven (11) hips due to dislocation/subluxation, two (2) hips due to adverse soft tissue reaction, ten (10) hips due to infection, eight (8) hips due to aseptic loosening associated with the stem, thirteen (13) hips due to aseptic loosening associated with the socket, four (4) hips due to periprosthetic fracture associated with the stem, one (1) hip due to malalignment of the socket, eight (8) hips due to wear of the acetabular component, four (4) hips due to lysis associated with the stem, four (4) hips due to lysis associated with the socket, two (2) hips due to implant fracture ¿ stem, one (1) hip due to implant fracture ¿ socket, one (1) hip due to dissociation of liner and ten (10) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 02-May-2003 and 26-Feb-2025 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred seven (207) revision THA procedures with the CONTOUR Reconstruction Acetabular Ring have been performed in the United Kingdom between 02-May-2003 and 26-Feb-2025. The mean yearly cumulative re-revision rates for the CONTOUR Reconstruction Ring were higher than the cumulative re-revision rates reported for the NJR THA revision class (All other Cemented, Cementless & Hybrid THR - referred as ¿the class¿ below) across all follow up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 17.1% (12.6%-22.3%) vs 11.5% (11.2%-11.9%) of the class.;o At 2nd postoperative year: 18.9% (14.1%-24.1%) vs 12.9% (12.5%-13.2%) of the class.;o At 3rd postoperative year: 21.4% (16.2%-27.0%) vs 13.8% (13.4%-14.1%) of the class.;o At 4th postoperative year: 22.7% (17.4%-28.7%) vs 14.5% (14.2%-14.9%) of the class.;o At 5th postoperative year: 25.0% (19.3%-31.1%) vs 15.4% (15.0%-15.7%) of the class.;o At 6th postoperative year: 25.0% (19.3%-31.2%) vs 16.2% (15.8%-16.5%) of the class.;o At 7th postoperative year: 25.8% (20.0%-32.2%) vs 16.8% (16.4%-17.2%) of the class.;o At 8th postoperative year: 26.8% (20.8%-33.2%) vs 17.5% (17.1%-17.9%) of the class.;o At 9th postoperative year: 27.9% (21.6%-34.5%) vs 18.2% (17.8%-18.6%) of the class.;o At 10th postoperative year: 27.9% (21.6%-35.0%) vs 18.9% (18.4%-19.3%) of the class.;o At 11th postoperative year: 29.2% (22.6%-36.5%) vs 19.6% (19.1%-20.0%) of the class.;o At 12th postoperative year: 30.8% (23.8%-38.5%) vs 20.3% (19.8%-20.8%) of the class.;o At 13th postoperative year: 30.8% (23.8%-39.5%) vs 20.9% (20.4%-21.5%) of the class.;o At 14th postoperative year: 30.8% (23.8%-40.0%) vs 21.5% (21.0%-22.1%) of the class.;o At 15th postoperative year: 30.8% (23.8%-41.1%) vs 22.1% (21.5%-22.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L54,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L55,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L56,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L57,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L58,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L59,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L60,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L61,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L62,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L63,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L64,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L65,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L66,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L67,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L68,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L69,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L70,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L71,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L72,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L73,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L74,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L75,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L76,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L77,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L78,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L79,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L80,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L81,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L82,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L83,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L84,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L85,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L86,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L87,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L88,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L89,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L90,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L91,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L92,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L93,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L94,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L95,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L96,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L97,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L98,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L99,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L100,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L101,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L102,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L103,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L104,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L105,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L106,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L107,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L108,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L109,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L110,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L111,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L112,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L113,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L114,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L115,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L116,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L117,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L118,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L119,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269331-1-L120,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using CONTOUR Reconstruction Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of four hundred fifty-nine (459) hips underwent revision THA procedures between 14-Apr-2003 and 29-Jan-2025, using Contour Reconstruction Rings. From these, one hundred twenty (120) hips were later re-revised due to the following complications: four (4) hips due to unexplained pain, twenty-seven (27) hips due to dislocation/subluxation, three (3) hips due to adverse soft tissue reaction, sixteen (16) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-five (35) hips due to aseptic loosening associated with the socket, nine (9) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, two (2) hips due to malalignment of the stem, two (2) hip due to malalignment of the socket, twelve (12) hips due to wear of the acetabular component, eight (8) hips due to lysis associated with the stem, seven (7) hips due to lysis associated with the socket, four (4) hips due to implant fracture ¿ stem, five (5) hips due to implant fracture ¿ socket, four (4) hips due to dissociation of liner and fourteen (14) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 14-Apr-2003 and 29-Jan-2025 in the United Kingdom.;;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 four hundred fifty-nine (459) revision THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 14-Apr-2003 and 29-Jan-2025. The mean yearly cumulative re-revision rates for the Contour Reconstruction Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the Contour Reconstruction Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. The following cumulative re-revision rates with 95% confidence intervals are presented in this report:;;¿ At 1st postoperative year: 16.3% (13.2%-19.6%) vs 11.9% (11.6%-12.2%) of the class.;¿ At 2nd postoperative year: 18.3% (15.0%-21.8%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 21.0% (17.5%-24.8%) vs 14.5% (14.1%-14.8%) of the class.;¿ At 4th postoperative year: 22.2% (18.5%-26.0%) vs 15.3% (15.0%-15.6%) of the class.;¿ At 5th postoperative year: 23.7% (19.9%-27.7%) vs 16.2% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 25.1% (21.1%-29.2%) vs 17.1% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 26.5% (22.4%-30.8%) vs 17.9% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 27.4% (23.2%-31.7%) vs 18.7% (18.3%-19.0%) of the class.;¿ At 9th postoperative year: 29.6% (25.1%-34.3%) vs 19.4% (19.0%-19.8%) of the class.;¿ At 10th postoperative year: 29.6% (25.1%-34.6%) vs 20.1% (19.7%-20.5%) of the class.;¿ At 11th postoperative year: 30.2% (25.6%-35.1%) vs 20.8% (20.4%-21.3%) of the class.;¿ At 12th postoperative year: 30.9% (26.2%-35.9%) vs 21.7% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 30.9% (26.2%-36.5%) vs 22.4% (22.0%-22.9%) of the class.;¿ At 14th postoperative year: 32.0% (27.0%-37.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 32.0% (27.0%-38.2%) vs 23.6% (23.0%-24.1%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L1,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L2,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L3,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L4,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L5,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L6,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L7,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L8,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L9,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L10,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L11,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L12,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L13,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L14,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L15,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L16,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L17,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L18,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L19,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L20,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L21,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L22,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L23,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L24,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L25,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L26,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L27,,10/23/2025,4/28/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two hundred thirty-three (233) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, twenty-seven (27) hips were later re-revised due to the following complications: one (1) hip due to unexplained pain, five (5) hips due to dislocation/subluxation, one (1) hip due to adverse soft tissue reaction, four (4) hips due to infection, seven (7) hips due to aseptic loosening associated with the stem, seven (7) hips due to aseptic loosening associated with the socket, three (3) hips due to periprosthetic fracture associated with the stem, one (1) hip due to wear of the acetabular component, one (1) hip due to lysis associated with the stem, one (1) hip due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, two (2) hips due to dissociation of liner and four (4) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. ;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the CONTOUR Acetabular Ring presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of two hundred thirty-three (233) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were significantly lower than the THA-NJR class (cemented, cementless and hybrid THA) across all follow up years based on the non-overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;o At 1st postoperative year: 6.5% (4.0%-9.6%) vs 11.6% (11.3%-11.9%) of the class.;o At 2nd postoperative year: 8.8% (5.8%-12.4%) vs 12.9% (12.6%-13.3%) of the class.;o At 3rd postoperative year: 9.3% (6.1%-13.1%) vs 13.8% (13.5%-14.2%) of the class.;o At 4th postoperative year: 9.3% (6.1%-13.2%) vs 14.6% (14.2%-14.9%) of the class.;o At 5th postoperative year: 10.4% (7.0%-14.3%) vs 15.4% (15.0%-15.8%) of the class.;o At 6th postoperative year: 10.4% (7.0%-14.5%) vs 16.2% (15.8%-16.6%) of the class.;o At 7th postoperative year: 11.0% (7.5%-15.2%) vs 16.8% (16.5%-17.2%) of the class.;o At 8th postoperative year: 11.7% (8.0%-16.1%) vs 17.5% (17.1%-18.0%) of the class.;o At 9th postoperative year: 12.5% (8.6%-17.1%) vs 18.3% (17.8%-18.7%) of the class.;o At 10th postoperative year: 12.5% (8.6%-17.4%) vs 18.9% (18.5%-19.4%) of the class.;o At 11th postoperative year: 12.5% (8.6%-17.7%) vs 19.6% (19.1%-20.1%) of the class.;o At 12th postoperative year: 12.5% (8.6%-18.0%) vs 20.4% (19.9%-20.9%) of the class.;o At 13th postoperative year: 12.5% (8.6%-18.6%) vs 21.0% (20.5%-21.5%) of the class.;o At 14th postoperative year: 12.5% (8.6%-19.5%) vs 21.6% (21.0%-22.1%) of the class.;o At 15th postoperative year: 12.5% (8.6%-20.4%) vs 22.1% (21.6%-22.8%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L28,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L29,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L30,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L31,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L32,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L33,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L34,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L35,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L36,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L37,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L38,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L39,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L40,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L41,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L42,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L43,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L44,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L45,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L46,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L47,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L48,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L49,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L50,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L51,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L52,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L53,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L54,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L55,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L56,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L57,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L58,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L59,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L60,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L61,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L62,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L63,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L64,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L65,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L66,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L67,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L68,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L69,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L70,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L71,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L72,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L73,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L74,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L75,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L76,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L77,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L78,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L79,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L80,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L81,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L82,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L83,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L84,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L85,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L86,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L87,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00269333-1-L88,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for re-revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of five hundred forty (540) hips underwent revision THA procedures between 06-May-2003 and 21-Nov-2024, using CONTOUR Reinforcement Rings. From these, eighty-eight (88) hips were later re-revised due to the following complications: two (2) hips due to unexplained pain, seventeen (17) hips due to dislocation/subluxation, five (5) hips due to adverse soft tissue reaction, ten (10) hips due to infection, nineteen (19) hips due to aseptic loosening associated with the stem, thirty-six (36) hips due to aseptic loosening associated with the socket, eleven (11) hips due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to malalignment associated with the stem, one (1) hip due to malalignment associated with the socket, five (5) hips due to wear of the acetabular component, three (3) hips due to lysis associated with the stem, ten (10) hips due to lysis associated with the socket, one (1) hip due to implant fracture ¿ stem, five (5) hips due to dissociation of liner and five (5) hips due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 06-May-2003 and 21-Nov-2024 in the United Kingdom.;;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 five hundred forty (540) revision THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 06-May-2003 and 21-Nov-2024. The mean yearly cumulative re-revision rates for the CONTOUR Reinforcement Ring were lower than the THA-NJR class across the 1 to 3 follow-up years based on the non-overlapping confidence intervals. From 4 to 15 follow-up years were in line with the class based on the overlapping confidence intervals. The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 7.1% (5.2%-9.3%) vs 12.0% (11.7%-12.2%) of the class.;¿ At 2nd postoperative year: 9.9% (7.6%-12.4%) vs 13.4% (13.1%-13.7%) of the class.;¿ At 3rd postoperative year: 11.2% (8.8%-13.9%) vs 14.5% (14.2%-14.8%) of the class.;¿ At 4th postoperative year: 12.6% (10.0%-15.4%) vs 15.3% (15.0%-15.7%) of the class.;¿ At 5th postoperative year: 13.8% (11.0%-16.8%) vs 16.3% (15.9%-16.6%) of the class.;¿ At 6th postoperative year: 14.6% (11.7%-17.7%) vs 17.2% (16.8%-17.5%) of the class.;¿ At 7th postoperative year: 15.7% (12.7%-19.0%) vs 18.0% (17.6%-18.3%) of the class.;¿ At 8th postoperative year: 17.1% (13.9%-20.6%) vs 18.7% (18.3%-19.1%) of the class.;¿ At 9th postoperative year: 17.8% (14.5%-21.5%) vs 19.5% (19.1%-19.9%) of the class.;¿ At 10th postoperative year: 18.3% (14.9%-22.1%) vs 20.2% (19.8%-20.6%) of the class.;¿ At 11th postoperative year: 18.3% (14.9%-22.4%) vs 20.9% (20.5%-21.3%) of the class.;¿ At 12th postoperative year: 18.9% (15.4%-22.8%) vs 21.8% (21.3%-22.2%) of the class.;¿ At 13th postoperative year: 18.9% (15.4%-23.3%) vs 22.5% (22.0%-23.0%) of the class.;¿ At 14th postoperative year: 20.1% (16.0%-24.4%) vs 23.0% (22.5%-23.5%) of the class.;¿ At 15th postoperative year: 20.1% (16.0%-24.9%) vs 23.6% (23.1%-24.2%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300444-1-L1,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eighty-nine (89) hips underwent primary THA procedures between 11-Sep-2003 and 19-Dec-2023, using CONTOUR Reconstruction Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of eighty-nine (89) hips underwent Primary THA procedures between 11-Sep-2003 and 19-Dec-2023, using CONTOUR Reconstruction Rings. From these, four (4) hips were later revised due to the following complications: two (2) hips due to dislocation/subluxation, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to wear of the acetabular component. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 11-Sep-2003 and 19-Dec-2023 in the United Kingdom.;;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 eighty-nine (89) primary THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 11-Sep-2003 and 19-Dec-2023. The mean yearly cumulative revision rate for the CONTOUR Reconstruction Ring was in line with all other Cemented Cups in the NJR (referred as ¿the class¿ below) based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;¿ At 1st postoperative year (53 at risk): 2.3% (0.6%-6.2%) vs 0.6% (0.6%-0.6%) of the class.;;NJR registry report does not include further rates since it is only reported for times where more than 40 patients remain at risk. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300444-1-L2,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eighty-nine (89) hips underwent primary THA procedures between 11-Sep-2003 and 19-Dec-2023, using CONTOUR Reconstruction Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of eighty-nine (89) hips underwent Primary THA procedures between 11-Sep-2003 and 19-Dec-2023, using CONTOUR Reconstruction Rings. From these, four (4) hips were later revised due to the following complications: two (2) hips due to dislocation/subluxation, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to wear of the acetabular component. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 11-Sep-2003 and 19-Dec-2023 in the United Kingdom.;;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 eighty-nine (89) primary THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 11-Sep-2003 and 19-Dec-2023. The mean yearly cumulative revision rate for the CONTOUR Reconstruction Ring was in line with all other Cemented Cups in the NJR (referred as ¿the class¿ below) based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;¿ At 1st postoperative year (53 at risk): 2.3% (0.6%-6.2%) vs 0.6% (0.6%-0.6%) of the class.;;NJR registry report does not include further rates since it is only reported for times where more than 40 patients remain at risk. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300444-1-L3,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eighty-nine (89) hips underwent primary THA procedures between 11-Sep-2003 and 19-Dec-2023, using CONTOUR Reconstruction Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of eighty-nine (89) hips underwent Primary THA procedures between 11-Sep-2003 and 19-Dec-2023, using CONTOUR Reconstruction Rings. From these, four (4) hips were later revised due to the following complications: two (2) hips due to dislocation/subluxation, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to wear of the acetabular component. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 11-Sep-2003 and 19-Dec-2023 in the United Kingdom.;;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 eighty-nine (89) primary THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 11-Sep-2003 and 19-Dec-2023. The mean yearly cumulative revision rate for the CONTOUR Reconstruction Ring was in line with all other Cemented Cups in the NJR (referred as ¿the class¿ below) based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;¿ At 1st postoperative year (53 at risk): 2.3% (0.6%-6.2%) vs 0.6% (0.6%-0.6%) of the class.;;NJR registry report does not include further rates since it is only reported for times where more than 40 patients remain at risk. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300444-1-L4,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reconstruction Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of eighty-nine (89) hips underwent primary THA procedures between 11-Sep-2003 and 19-Dec-2023, using CONTOUR Reconstruction Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reconstruction Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of eighty-nine (89) hips underwent Primary THA procedures between 11-Sep-2003 and 19-Dec-2023, using CONTOUR Reconstruction Rings. From these, four (4) hips were later revised due to the following complications: two (2) hips due to dislocation/subluxation, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to wear of the acetabular component. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available.;;Timeframe of Registry data: Implantations conducted between 11-Sep-2003 and 19-Dec-2023 in the United Kingdom.;;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 eighty-nine (89) primary THA procedures with the CONTOUR Acetabular Reconstruction Ring have been performed in the United Kingdom between 11-Sep-2003 and 19-Dec-2023. The mean yearly cumulative revision rate for the CONTOUR Reconstruction Ring was in line with all other Cemented Cups in the NJR (referred as ¿the class¿ below) based on the overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;¿ At 1st postoperative year (53 at risk): 2.3% (0.6%-6.2%) vs 0.6% (0.6%-0.6%) of the class.;;NJR registry report does not include further rates since it is only reported for times where more than 40 patients remain at risk. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300502-1-L1,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, twelve (12) hips were later revised due to the following complications: one (1) hip due to unexplained pain, four (4) hips due to dislocation/subluxation, three (3) hips due to infection, one (1) hip due to aseptic loosening associated with the stem, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to implant fracture ¿ socket, and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 25-Jun-2003 and 29-Nov-2023 in the United Kingdom.;;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 and four (104) primary THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 25-Jun-2003 and 29-Nov-2023. ;;The mean yearly cumulative revision rates for the CONTOUR Reinforcement Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reinforcement Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ 1st postoperative year: 3.0% (1.0%¿6.3%) vs 0.6% (0.6%¿0.6%).;¿ 2nd postoperative year: 5.1% (2.1%¿9.4%) vs 0.8% (0.8%¿0.9%).;¿ 3rd postoperative year: 6.2% (2.8%¿10.9%) vs 1.1% (1.1%¿1.1%).;¿ 4th postoperative year: 7.4% (3.6%¿12.6%) vs 1.3% (1.3%¿1.3%).;¿ 5th postoperative year: 8.7% (4.4%¿14.5%) vs 1.5% (1.5%¿1.5%).;¿ 6th postoperative year: 11.5% (6.3%¿18.2%) vs 1.7% (1.7%¿1.7%).;¿ 7th postoperative year: 13.1% (7.4%¿20.4%) vs 1.9% (1.9%¿2.0%).;¿ 8th postoperative year: 13.1% (7.4%¿21.0%) vs 2.2% (2.1%¿2.2%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300502-1-L2,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, twelve (12) hips were later revised due to the following complications: one (1) hip due to unexplained pain, four (4) hips due to dislocation/subluxation, three (3) hips due to infection, one (1) hip due to aseptic loosening associated with the stem, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to implant fracture ¿ socket, and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 25-Jun-2003 and 29-Nov-2023 in the United Kingdom.;;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 and four (104) primary THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 25-Jun-2003 and 29-Nov-2023. ;;The mean yearly cumulative revision rates for the CONTOUR Reinforcement Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reinforcement Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ 1st postoperative year: 3.0% (1.0%¿6.3%) vs 0.6% (0.6%¿0.6%).;¿ 2nd postoperative year: 5.1% (2.1%¿9.4%) vs 0.8% (0.8%¿0.9%).;¿ 3rd postoperative year: 6.2% (2.8%¿10.9%) vs 1.1% (1.1%¿1.1%).;¿ 4th postoperative year: 7.4% (3.6%¿12.6%) vs 1.3% (1.3%¿1.3%).;¿ 5th postoperative year: 8.7% (4.4%¿14.5%) vs 1.5% (1.5%¿1.5%).;¿ 6th postoperative year: 11.5% (6.3%¿18.2%) vs 1.7% (1.7%¿1.7%).;¿ 7th postoperative year: 13.1% (7.4%¿20.4%) vs 1.9% (1.9%¿2.0%).;¿ 8th postoperative year: 13.1% (7.4%¿21.0%) vs 2.2% (2.1%¿2.2%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300502-1-L3,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, twelve (12) hips were later revised due to the following complications: one (1) hip due to unexplained pain, four (4) hips due to dislocation/subluxation, three (3) hips due to infection, one (1) hip due to aseptic loosening associated with the stem, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to implant fracture ¿ socket, and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 25-Jun-2003 and 29-Nov-2023 in the United Kingdom.;;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 and four (104) primary THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 25-Jun-2003 and 29-Nov-2023. ;;The mean yearly cumulative revision rates for the CONTOUR Reinforcement Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reinforcement Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ 1st postoperative year: 3.0% (1.0%¿6.3%) vs 0.6% (0.6%¿0.6%).;¿ 2nd postoperative year: 5.1% (2.1%¿9.4%) vs 0.8% (0.8%¿0.9%).;¿ 3rd postoperative year: 6.2% (2.8%¿10.9%) vs 1.1% (1.1%¿1.1%).;¿ 4th postoperative year: 7.4% (3.6%¿12.6%) vs 1.3% (1.3%¿1.3%).;¿ 5th postoperative year: 8.7% (4.4%¿14.5%) vs 1.5% (1.5%¿1.5%).;¿ 6th postoperative year: 11.5% (6.3%¿18.2%) vs 1.7% (1.7%¿1.7%).;¿ 7th postoperative year: 13.1% (7.4%¿20.4%) vs 1.9% (1.9%¿2.0%).;¿ 8th postoperative year: 13.1% (7.4%¿21.0%) vs 2.2% (2.1%¿2.2%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300502-1-L4,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, twelve (12) hips were later revised due to the following complications: one (1) hip due to unexplained pain, four (4) hips due to dislocation/subluxation, three (3) hips due to infection, one (1) hip due to aseptic loosening associated with the stem, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to implant fracture ¿ socket, and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 25-Jun-2003 and 29-Nov-2023 in the United Kingdom.;;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 and four (104) primary THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 25-Jun-2003 and 29-Nov-2023. ;;The mean yearly cumulative revision rates for the CONTOUR Reinforcement Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reinforcement Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ 1st postoperative year: 3.0% (1.0%¿6.3%) vs 0.6% (0.6%¿0.6%).;¿ 2nd postoperative year: 5.1% (2.1%¿9.4%) vs 0.8% (0.8%¿0.9%).;¿ 3rd postoperative year: 6.2% (2.8%¿10.9%) vs 1.1% (1.1%¿1.1%).;¿ 4th postoperative year: 7.4% (3.6%¿12.6%) vs 1.3% (1.3%¿1.3%).;¿ 5th postoperative year: 8.7% (4.4%¿14.5%) vs 1.5% (1.5%¿1.5%).;¿ 6th postoperative year: 11.5% (6.3%¿18.2%) vs 1.7% (1.7%¿1.7%).;¿ 7th postoperative year: 13.1% (7.4%¿20.4%) vs 1.9% (1.9%¿2.0%).;¿ 8th postoperative year: 13.1% (7.4%¿21.0%) vs 2.2% (2.1%¿2.2%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300502-1-L5,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, twelve (12) hips were later revised due to the following complications: one (1) hip due to unexplained pain, four (4) hips due to dislocation/subluxation, three (3) hips due to infection, one (1) hip due to aseptic loosening associated with the stem, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to implant fracture ¿ socket, and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 25-Jun-2003 and 29-Nov-2023 in the United Kingdom.;;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 and four (104) primary THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 25-Jun-2003 and 29-Nov-2023. ;;The mean yearly cumulative revision rates for the CONTOUR Reinforcement Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reinforcement Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ 1st postoperative year: 3.0% (1.0%¿6.3%) vs 0.6% (0.6%¿0.6%).;¿ 2nd postoperative year: 5.1% (2.1%¿9.4%) vs 0.8% (0.8%¿0.9%).;¿ 3rd postoperative year: 6.2% (2.8%¿10.9%) vs 1.1% (1.1%¿1.1%).;¿ 4th postoperative year: 7.4% (3.6%¿12.6%) vs 1.3% (1.3%¿1.3%).;¿ 5th postoperative year: 8.7% (4.4%¿14.5%) vs 1.5% (1.5%¿1.5%).;¿ 6th postoperative year: 11.5% (6.3%¿18.2%) vs 1.7% (1.7%¿1.7%).;¿ 7th postoperative year: 13.1% (7.4%¿20.4%) vs 1.9% (1.9%¿2.0%).;¿ 8th postoperative year: 13.1% (7.4%¿21.0%) vs 2.2% (2.1%¿2.2%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300502-1-L6,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, twelve (12) hips were later revised due to the following complications: one (1) hip due to unexplained pain, four (4) hips due to dislocation/subluxation, three (3) hips due to infection, one (1) hip due to aseptic loosening associated with the stem, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to implant fracture ¿ socket, and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 25-Jun-2003 and 29-Nov-2023 in the United Kingdom.;;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 and four (104) primary THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 25-Jun-2003 and 29-Nov-2023. ;;The mean yearly cumulative revision rates for the CONTOUR Reinforcement Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reinforcement Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ 1st postoperative year: 3.0% (1.0%¿6.3%) vs 0.6% (0.6%¿0.6%).;¿ 2nd postoperative year: 5.1% (2.1%¿9.4%) vs 0.8% (0.8%¿0.9%).;¿ 3rd postoperative year: 6.2% (2.8%¿10.9%) vs 1.1% (1.1%¿1.1%).;¿ 4th postoperative year: 7.4% (3.6%¿12.6%) vs 1.3% (1.3%¿1.3%).;¿ 5th postoperative year: 8.7% (4.4%¿14.5%) vs 1.5% (1.5%¿1.5%).;¿ 6th postoperative year: 11.5% (6.3%¿18.2%) vs 1.7% (1.7%¿1.7%).;¿ 7th postoperative year: 13.1% (7.4%¿20.4%) vs 1.9% (1.9%¿2.0%).;¿ 8th postoperative year: 13.1% (7.4%¿21.0%) vs 2.2% (2.1%¿2.2%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300502-1-L7,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, twelve (12) hips were later revised due to the following complications: one (1) hip due to unexplained pain, four (4) hips due to dislocation/subluxation, three (3) hips due to infection, one (1) hip due to aseptic loosening associated with the stem, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to implant fracture ¿ socket, and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 25-Jun-2003 and 29-Nov-2023 in the United Kingdom.;;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 and four (104) primary THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 25-Jun-2003 and 29-Nov-2023. ;;The mean yearly cumulative revision rates for the CONTOUR Reinforcement Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reinforcement Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ 1st postoperative year: 3.0% (1.0%¿6.3%) vs 0.6% (0.6%¿0.6%).;¿ 2nd postoperative year: 5.1% (2.1%¿9.4%) vs 0.8% (0.8%¿0.9%).;¿ 3rd postoperative year: 6.2% (2.8%¿10.9%) vs 1.1% (1.1%¿1.1%).;¿ 4th postoperative year: 7.4% (3.6%¿12.6%) vs 1.3% (1.3%¿1.3%).;¿ 5th postoperative year: 8.7% (4.4%¿14.5%) vs 1.5% (1.5%¿1.5%).;¿ 6th postoperative year: 11.5% (6.3%¿18.2%) vs 1.7% (1.7%¿1.7%).;¿ 7th postoperative year: 13.1% (7.4%¿20.4%) vs 1.9% (1.9%¿2.0%).;¿ 8th postoperative year: 13.1% (7.4%¿21.0%) vs 2.2% (2.1%¿2.2%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300502-1-L8,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, twelve (12) hips were later revised due to the following complications: one (1) hip due to unexplained pain, four (4) hips due to dislocation/subluxation, three (3) hips due to infection, one (1) hip due to aseptic loosening associated with the stem, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to implant fracture ¿ socket, and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 25-Jun-2003 and 29-Nov-2023 in the United Kingdom.;;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 and four (104) primary THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 25-Jun-2003 and 29-Nov-2023. ;;The mean yearly cumulative revision rates for the CONTOUR Reinforcement Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reinforcement Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ 1st postoperative year: 3.0% (1.0%¿6.3%) vs 0.6% (0.6%¿0.6%).;¿ 2nd postoperative year: 5.1% (2.1%¿9.4%) vs 0.8% (0.8%¿0.9%).;¿ 3rd postoperative year: 6.2% (2.8%¿10.9%) vs 1.1% (1.1%¿1.1%).;¿ 4th postoperative year: 7.4% (3.6%¿12.6%) vs 1.3% (1.3%¿1.3%).;¿ 5th postoperative year: 8.7% (4.4%¿14.5%) vs 1.5% (1.5%¿1.5%).;¿ 6th postoperative year: 11.5% (6.3%¿18.2%) vs 1.7% (1.7%¿1.7%).;¿ 7th postoperative year: 13.1% (7.4%¿20.4%) vs 1.9% (1.9%¿2.0%).;¿ 8th postoperative year: 13.1% (7.4%¿21.0%) vs 2.2% (2.1%¿2.2%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300502-1-L9,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, twelve (12) hips were later revised due to the following complications: one (1) hip due to unexplained pain, four (4) hips due to dislocation/subluxation, three (3) hips due to infection, one (1) hip due to aseptic loosening associated with the stem, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to implant fracture ¿ socket, and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 25-Jun-2003 and 29-Nov-2023 in the United Kingdom.;;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 and four (104) primary THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 25-Jun-2003 and 29-Nov-2023. ;;The mean yearly cumulative revision rates for the CONTOUR Reinforcement Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reinforcement Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ 1st postoperative year: 3.0% (1.0%¿6.3%) vs 0.6% (0.6%¿0.6%).;¿ 2nd postoperative year: 5.1% (2.1%¿9.4%) vs 0.8% (0.8%¿0.9%).;¿ 3rd postoperative year: 6.2% (2.8%¿10.9%) vs 1.1% (1.1%¿1.1%).;¿ 4th postoperative year: 7.4% (3.6%¿12.6%) vs 1.3% (1.3%¿1.3%).;¿ 5th postoperative year: 8.7% (4.4%¿14.5%) vs 1.5% (1.5%¿1.5%).;¿ 6th postoperative year: 11.5% (6.3%¿18.2%) vs 1.7% (1.7%¿1.7%).;¿ 7th postoperative year: 13.1% (7.4%¿20.4%) vs 1.9% (1.9%¿2.0%).;¿ 8th postoperative year: 13.1% (7.4%¿21.0%) vs 2.2% (2.1%¿2.2%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300502-1-L10,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, twelve (12) hips were later revised due to the following complications: one (1) hip due to unexplained pain, four (4) hips due to dislocation/subluxation, three (3) hips due to infection, one (1) hip due to aseptic loosening associated with the stem, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to implant fracture ¿ socket, and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 25-Jun-2003 and 29-Nov-2023 in the United Kingdom.;;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 and four (104) primary THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 25-Jun-2003 and 29-Nov-2023. ;;The mean yearly cumulative revision rates for the CONTOUR Reinforcement Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reinforcement Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ 1st postoperative year: 3.0% (1.0%¿6.3%) vs 0.6% (0.6%¿0.6%).;¿ 2nd postoperative year: 5.1% (2.1%¿9.4%) vs 0.8% (0.8%¿0.9%).;¿ 3rd postoperative year: 6.2% (2.8%¿10.9%) vs 1.1% (1.1%¿1.1%).;¿ 4th postoperative year: 7.4% (3.6%¿12.6%) vs 1.3% (1.3%¿1.3%).;¿ 5th postoperative year: 8.7% (4.4%¿14.5%) vs 1.5% (1.5%¿1.5%).;¿ 6th postoperative year: 11.5% (6.3%¿18.2%) vs 1.7% (1.7%¿1.7%).;¿ 7th postoperative year: 13.1% (7.4%¿20.4%) vs 1.9% (1.9%¿2.0%).;¿ 8th postoperative year: 13.1% (7.4%¿21.0%) vs 2.2% (2.1%¿2.2%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300502-1-L11,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, twelve (12) hips were later revised due to the following complications: one (1) hip due to unexplained pain, four (4) hips due to dislocation/subluxation, three (3) hips due to infection, one (1) hip due to aseptic loosening associated with the stem, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to implant fracture ¿ socket, and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 25-Jun-2003 and 29-Nov-2023 in the United Kingdom.;;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 and four (104) primary THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 25-Jun-2003 and 29-Nov-2023. ;;The mean yearly cumulative revision rates for the CONTOUR Reinforcement Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reinforcement Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ 1st postoperative year: 3.0% (1.0%¿6.3%) vs 0.6% (0.6%¿0.6%).;¿ 2nd postoperative year: 5.1% (2.1%¿9.4%) vs 0.8% (0.8%¿0.9%).;¿ 3rd postoperative year: 6.2% (2.8%¿10.9%) vs 1.1% (1.1%¿1.1%).;¿ 4th postoperative year: 7.4% (3.6%¿12.6%) vs 1.3% (1.3%¿1.3%).;¿ 5th postoperative year: 8.7% (4.4%¿14.5%) vs 1.5% (1.5%¿1.5%).;¿ 6th postoperative year: 11.5% (6.3%¿18.2%) vs 1.7% (1.7%¿1.7%).;¿ 7th postoperative year: 13.1% (7.4%¿20.4%) vs 1.9% (1.9%¿2.0%).;¿ 8th postoperative year: 13.1% (7.4%¿21.0%) vs 2.2% (2.1%¿2.2%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00300502-1-L12,,1/23/2026,12/4/2025,CONTOUR Acetabular System,CONTOUR Acetabular Rings (Reinforcement Rings),,,,,,K962541,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the NJR, no specific reason for revision can be definitively linked to the individual CONTOUR Reinforcement Ring reported through this line item.","Reporting Quarter: 4 (Oct 1 - Dec 31, 2025);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR) from United Kingdom, a total of one hundred and four (104) hips underwent primary THA procedures between 25-Jun-2003 and 29-Nov-2023, using CONTOUR Reinforcement Rings. From these, twelve (12) hips were later revised due to the following complications: one (1) hip due to unexplained pain, four (4) hips due to dislocation/subluxation, three (3) hips due to infection, one (1) hip due to aseptic loosening associated with the stem, two (2) hips due to aseptic loosening associated with the socket, one (1) hip due to periprosthetic fracture associated with the stem, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to implant fracture ¿ socket, and one (1) hip due to other-unknown reasons. It should be noted that multiple reasons may be listed for one revision procedure. No further information is available. ;;Timeframe of Registry data: Implantations conducted between 25-Jun-2003 and 29-Nov-2023 in the United Kingdom.;;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 and four (104) primary THA procedures with the CONTOUR Acetabular Reinforcement Ring have been performed in the United Kingdom between 25-Jun-2003 and 29-Nov-2023. ;;The mean yearly cumulative revision rates for the CONTOUR Reinforcement Ring were higher than all other THR in the NJR (referred as ¿the class¿ below) across all follow-up years based on the non-overlapping confidence intervals. This may be expected based on the clinical scenarios which the CONTOUR Reinforcement Ring will be used, such as large cavitary defects of the acetabulum, segmental defects that involve more than 50% of the acetabulum and pelvic discontinuity. Thus, the severity of the patient condition to enable device use may also impact survivorship of the device long-term. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;¿ 1st postoperative year: 3.0% (1.0%¿6.3%) vs 0.6% (0.6%¿0.6%).;¿ 2nd postoperative year: 5.1% (2.1%¿9.4%) vs 0.8% (0.8%¿0.9%).;¿ 3rd postoperative year: 6.2% (2.8%¿10.9%) vs 1.1% (1.1%¿1.1%).;¿ 4th postoperative year: 7.4% (3.6%¿12.6%) vs 1.3% (1.3%¿1.3%).;¿ 5th postoperative year: 8.7% (4.4%¿14.5%) vs 1.5% (1.5%¿1.5%).;¿ 6th postoperative year: 11.5% (6.3%¿18.2%) vs 1.7% (1.7%¿1.7%).;¿ 7th postoperative year: 13.1% (7.4%¿20.4%) vs 1.9% (1.9%¿2.0%).;¿ 8th postoperative year: 13.1% (7.4%¿21.0%) vs 2.2% (2.1%¿2.2%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;
BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN REVISION JOINT REPLACEMENT PROCEDURES: 1.PRIMARY THA PROCEDURES: - CONTOUR RECONSTRUCTION RING COMPONENTS: IMPLANTED IN EIGHTY-NINE (89) HIPS BETWEEN 11-SEP-2003 AND 19-DEC-2023. FROM THESE, FOUR (4) HIPS WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: TWO (2) HIPS DUE TO DISLOCATION/SUBLUXATION, TWO (2) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO WEAR OF THE ACETABULAR COMPONENT. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. - CONTOUR REINFORCEMENT RING COMPONENTS: IMPLANTED IN ONE HUNDRED AND FOUR (104) HIPS BETWEEN 25-JUN-2003 AND 29-NOV-2023. FROM THESE, TWELVE (12) HIPS WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: ONE (1) HIP DUE TO UNEXPLAINED PAIN, FOUR (4) HIPS DUE TO DISLOCATION/SUBLUXATION, THREE (3) HIPS DUE TO INFECTION, ONE (1) HIP DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, TWO (2) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO IMPLANT FRACTURE ¿ SOCKET, AND ONE (1) HIP DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. 2. REVISION THA PROCEDURES: - CONTOUR RECONSTRUCTION RING COMPONENTS: IMPLANTED IN FOUR HUNDRED FIFTY-NINE (459) HIPS BETWEEN 14-APR-2003 AND 29-JAN-2025. FROM THESE, ONE HUNDRED TWENTY (120) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: FOUR (4) HIPS DUE TO UNEXPLAINED PAIN, TWENTY-SEVEN (27) HIPS DUE TO DISLOCATION/SUBLUXATION, THREE (3) HIPS DUE TO ADVERSE SOFT TISSUE REACTION, SIXTEEN (16) HIPS DUE TO INFECTION, NINETEEN (19) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, THIRTY-FIVE (35) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, NINE (9) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE SOCKET, TWO (2) HIPS DUE TO MALALIGNMENT OF THE STEM, TWO (2) HIP DUE TO MALALIGNMENT OF THE SOCKET, TWELVE (12) HIPS DUE TO WEAR OF THE ACETABULAR COMPONENT, EIGHT (8) HIPS DUE TO LYSIS ASSOCIATED WITH THE STEM, SEVEN (7) HIPS DUE TO LYSIS ASSOCIATED WITH THE SOCKET, FOUR (4) HIPS DUE TO IMPLANT FRACTURE ¿ STEM, FIVE (5) HIPS DUE TO IMPLANT FRACTURE ¿ SOCKET, FOUR (4) HIPS DUE TO DISSOCIATION OF LINER AND FOURTEEN (14) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. - CONTOUR REINFORCEMENT RING COMPONENTS: IMPLANTED IN FIVE HUNDRED FORTY (540) HIPS BETWEEN 06-MAY-2003 AND 21-NOV-2024. FROM THESE, EIGHTY-EIGHT (88) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: TWO (2) HIPS DUE TO UNEXPLAINED PAIN, SEVENTEEN (17) HIPS DUE TO DISLOCATION/SUBLUXATION, FIVE (5) HIPS DUE TO ADVERSE SOFT TISSUE REACTION, TEN (10) HIPS DUE TO INFECTION, NINETEEN (19) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, THIRTY-SIX (36) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, ELEVEN (11) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO MALALIGNMENT ASSOCIATED WITH THE STEM, ONE (1) HIP DUE TO MALALIGNMENT ASSOCIATED WITH THE SOCKET, FIVE (5) HIPS DUE TO WEAR OF THE ACETABULAR COMPONENT, THREE (3) HIPS DUE TO LYSIS ASSOCIATED WITH THE STEM, TEN (10) HIPS DUE TO LYSIS ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO IMPLANT FRACTURE ¿ STEM, FIVE (5) HIPS DUE TO DISSOCIATION OF LINER AND FIVE (5) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF SIXTEEN (16) REVISIONS AND TWO HUNDRED AND EIGHT (208) RE-REVISIONS HAVE BEEN REPORTED IN THE NJR FOR THE SMITH+NEPHEW DEVICES REFERENCED ABOVE, RESULTING IN A TOTAL OF TWO HUNDRED AND TWENTY-FOUR (224) EVENTS SUMMARIZED THROUGH THIS 3500A FORM.
IT WAS REPORTED THAT, IN THE NATIONAL JOINT REGISTRY (NJR) FROM THE UNITED KINGDOM, A TOTAL OF TWO HUNDRED SEVEN (207) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 02-MAY-2003 AND 26-FEB-2025, USING CONTOUR RECONSTRUCTION RINGS. FROM THESE, FIFTY-THREE (53) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: TWO (2) HIPS DUE TO UNEXPLAINED PAIN, ELEVEN (11) HIPS DUE TO DISLOCATION/SUBLUXATION, TWO (2) HIPS DUE TO ADVERSE SOFT TISSUE REACTION, TEN (10) HIPS DUE TO INFECTION, EIGHT (8) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, THIRTEEN (13) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, FOUR (4) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, ONE (1) HIP DUE TO MALALIGNMENT OF THE SOCKET, EIGHT (8) HIPS DUE TO WEAR OF THE ACETABULAR COMPONENT, FOUR (4) HIPS DUE TO LYSIS ASSOCIATED WITH THE STEM, FOUR (4) HIPS DUE TO LYSIS ASSOCIATED WITH THE SOCKET, TWO (2) HIPS DUE TO IMPLANT FRACTURE ¿ STEM, ONE (1) HIP DUE TO IMPLANT FRACTURE ¿ SOCKET, ONE (1) HIP DUE TO DISSOCIATION OF LINER AND TEN (10) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. TIMEFRAME OF REGISTRY DATA: IMPLANTATIONS CONDUCTED BETWEEN 02-MAY-2003 AND 26-FEB-2025 IN THE UNITED KINGDOM.
BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN REVISION JOINT REPLACEMENT PROCEDURES: 1. REVISION THA PROCEDURES: - CONTOUR RECONSTRUCTION RING COMPONENTS: IMPLANTED IN TWO HUNDRED SEVEN (207) HIPS BETWEEN (B)(6)2003 AND (B)(6) 2025. FROM THESE, FIFTY-THREE (53) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: TWO (2) HIPS DUE TO UNEXPLAINED PAIN, ELEVEN (11) HIPS DUE TO DISLOCATION/SUBLUXATION, TWO (2) HIPS DUE TO ADVERSE SOFT TISSUE REACTION, TEN (10) HIPS DUE TO INFECTION, EIGHT (8) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, THIRTEEN (13) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, FOUR (4) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, ONE (1) HIP DUE TO MALALIGNMENT OF THE SOCKET, EIGHT (8) HIPS DUE TO WEAR OF THE ACETABULAR COMPONENT, FOUR (4) HIPS DUE TO LYSIS ASSOCIATED WITH THE STEM, FOUR (4) HIPS DUE TO LYSIS ASSOCIATED WITH THE SOCKET, TWO (2) HIPS DUE TO IMPLANT FRACTURE ¿ STEM, ONE (1) HIP DUE TO IMPLANT FRACTURE ¿ SOCKET, ONE (1) HIP DUE TO DISSOCIATION OF LINER AND TEN (10) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. - CONTOUR REINFORCEMENT RING COMPONENTS: IMPLANTED IN TWO HUNDRED THIRTY-THREE (233) HIPS BETWEEN (B)(6) 2003 AND (B)(6) 2024. FROM THESE, TWENTY-SEVEN (27) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: ONE (1) HIP DUE TO UNEXPLAINED PAIN, FIVE (5) HIPS DUE TO DISLOCATION/SUBLUXATION, ONE (1) HIP DUE TO ADVERSE SOFT TISSUE REACTION, FOUR (4) HIPS DUE TO INFECTION, SEVEN (7) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, SEVEN (7) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, THREE (3) HIPS DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, ONE (1) HIP DUE TO WEAR OF THE ACETABULAR COMPONENT, ONE (1) HIP DUE TO LYSIS ASSOCIATED WITH THE STEM, ONE (1) HIP DUE TO LYSIS ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO IMPLANT FRACTURE ¿ STEM, TWO (2) HIPS DUE TO DISSOCIATION OF LINER AND FOUR (4) HIPS DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS MAY BE LISTED FOR ONE REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF EIGHTY (80) RE-REVISIONS HAVE BEEN REPORTED IN THE NJR FOR THE CONTOUR RECONSTRUCTION RING COMPONENTS, AND CONTOUR REINFORCEMENT RING COMPONENTS REFERENCED THROUGH THIS 3500A FORM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1461928 | CONTOUR ACETABULAR RECONSTRUCTION RING | MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS | JDJ | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Unknown | Required Intervention |