CONTOUR ACETABULAR REINFORCEMENT RING

Description of Event or Problem

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;

Description of Event or Problem

: 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. NO FURTHER INFORMATION IS AVAILABLE. TIMEFRAME OF REGISTRY DATA: IMPLANTATIONS CONDUCTED BETWEEN 06-MAY-2003 AND 21-NOV-2024 IN THE UNITED KINGDOM.

Additional Manufacturer Narrative

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. 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 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.

Additional Manufacturer Narrative

H11: THIS REPORT IS SUBMITTED IN RESPONSE TO THE FDA¿S OBSERVATIONS REGARDING SMITH+NEPHEW¿S (S+N) SUMMARY MDR REPORTING PRACTICES UNDER (B)(6), COMMUNICATED ON (B)(6) 2025. AS A RESULT, THE DATA PREVIOUSLY REPORTED THROUGH MDR IS NO LONGER VALID AS IT WILL BE MIGRATED AND SUBMITTED UNDER MDR 1020279-2025-01026 BY THE END OF THE THIRD REPORTING QUARTER, AS AGREED WITH THE FDA.